Philips CPAP Recall – Everything You Need to Know

Philips CPAP recall

On Monday, June 14th, Philips Respironics issued a voluntary recall on nearly all of their CPAP, APAP, and BiPAP machines sold from 2009 until today, with some exceptions. 

On June 30th 2021, the FDA issued a Philips CPAP recall, which also includes BiPAP and Ventilator machines due to potential health risks. Philips advised the FDA of potential health risks related to sound abatement foam used in specific Philips Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators.

Philips reports that the sound dampening foam used inside some of their machines can break down over time, which can cause tiny particles of black foam to enter the device’s air chambers.

Potential safety hazards Philips has reported 

  • The potential risks of exposure to degraded foam include irritation (skin, eye, and respiratory tract), inflammatory response, headache, asthma, adverse effects to other organs (e.g. kidneys and liver) and cancer-causing affects.
  • The potential risks of exposure to chemical emissions include headache/dizziness, irritation (eyes, nose, respiratory tract, skin), hypersensitivity, nausea/vomiting, toxic and cancer-causing affects.

Which Machines have been recalled?

Continuous Ventilator, Minimum Ventilatory Support, Facility Use
E30 (Emergency Use Authorization)
Continuous Ventilator, Non-life Supporting
DreamStation ASV
DreamStation ST, AVAPS
SystemOne ASV4
C Series ASV, S/T, AVAPS
OmniLab Advanced Plus In-Lab Titration Device
Non-continuous Ventilator
SystemOne (Q Series)
DreamStation (CPAP, Auto CPAP, BiPAP)
DreamStation Go (CPAP, APAP)
Dorma 400, 500 CPAP
REMstar SE Auto CPAP
Continuous Ventilator
Trilogy 100 Ventilator
Trilogy 200 Ventilator
Garbin Plus, Aeris, LifeVent Ventilator
Continuous Ventilator, Minimum Ventilatory Support, Facility Use
A-Series BiPAP Hybrid A30 (not marketed in US)
A-Series BiPAP V30 Auto Ventilator
Continuous Ventilator, Non-life Supporting
A-Series BiPAP A40 (not marketed in US)
A-Series BiPAP A30 (not marketed in US)

If your device is on the list of affected Machines

Should you continue using your machine if it is on the recall list? 

According to Philips Respironics:

  • For patients using affected BiLevel PAP and CPAP devices: Discontinue use of your device and work with your physician or Durable Medical Equipment (DME) provider to determine the most appropriate options for continued treatment. To continue use of your device due to lack of alternatives, consult with your physician to determine if the benefit of continuing therapy with your device outweighs the risks identified in the recall notification.*
  • For patients using affected life-sustaining mechanical ventilator devices: Do not stop or alter your prescribed therapy until you have talked to your physician. Philips recognizes that alternate ventilator options for therapy may not exist or may be severely limited for patients who require a ventilator for life-sustaining therapy, or in cases where therapy disruption is unacceptable. In these situations, and at the discretion of the treating clinical team, the benefit of continued usage of these ventilator devices may outweigh the risks identified in the recall notification.*

*  This is a recall notification for the US only, and a field safety notice for the rest of the world

If your device is not on the list of affected devices

Continue CPAP as prescribed. The Philips CPAP recall does not apply to you.

How Long Will It Take for Philips Respironics To Address All Recalled Machines?

Philips Respironics Chief Executive Frans van Houten said, “We’re going to put all our capacity to focus entirely on replacing and repairing these units,” a process he said would likely take a year

It will take quite a long time to learn about the potential long-term effects of exposure to this degraded sound insulating foam. If you or a loved one has been exposed to black debris inside a machine that is part of the Philips CPAP recall, call the experienced defective medical device attorneys at Cowan & Hilgeman Law. Call (937) 222-2030 today to schedule your free, no-obligation consultation.


Ohio Legislature Passes Laws Protecting Nursing Homes from Liability During COVID-19 Crisis

Nursing home liability covid coronavirus

Understanding the extent and impact of the COVID-19 pandemic is a difficult task. Researchers are still searching for a cure for the virus, and meanwhile cases are skyrocketing across the US. In Ohio, one of the most impacted sectors of the state has been to residents in nursing homes and other related healthcare fields.

As of June, the Ohio Department of Health found 1,860 of the 2,611 confirmed or probable COVID deaths were those of Nursing home residents. That’s a whopping 70% of total cases, leading to an understandably upset and fearful public. With potential lawsuits looming, Ohio lawmakers are taking steps to address how these cases will be handled.

Two bills have been put in place to protect businesses, especially nursing homes, from COVID related suits: Ohio Legislature House Bill 606 and Senate Bill 308. The spirit of these bills are very similar, but the Senate Bill reaches beyond the protection provided in the House Bill. 

HB 606 was passed on May 28th, 2020, and basically is attempting to protect a variety of groups, particularly health care workers/providers. This bill would grant immunity to healthcare providers from “professional discipline or tort liability for acts, omissions, or decisions related to the provision of health care services, including the decision to withhold health care services.” Furthermore, it would protect them from any liability that was a result of a director’s order or executive order and liability from the inability to diagnose, test, or treat  an illness due to these same circumstances.

While this does provide an enormous amount of protection to providers, they can still be held liable in the instance of “gross negligence” (conduct that is indifferent to the rights of those under their care) or “if their act, omission, decision, or compliance constitutes reckless disregard for the consequences, constitutes willful or wanton misconduct.” 

The last item in the bill grants protection to businesses from suits that claim liability for exposure, transmission, or contraction of COVID-19.  Again, the business can be held liable in the case of reckless or intentional misconduct, and willful wanton misconduct. Beyond this, an important aspect of the bill states that “executive orders, director’s orders, and federal guidance do not establish a new cause of action and are not admissible evidence at trial.”

On June 3rd, 2020 SB 308 was passed, and it expands upon the ideas laid forth in HB 606. It has an identical take for the stance on healthcare providers, and about what can be admissible in court. Yet is has two root components that are extremely different. The first is that beyond protecting a business in the course of business, but also protects them from “liability for any act or omission that may occur in the course of the business providing services as a result of or in response to COVID-19.”

The second aspect that is different from HB 606 is the amount of time this protection is applied. H.B. 606 will apply retroactively from the Governor’s Executive Order 2020-01D, issued on March 9, 2020, through to December 31, 2020, while SB 308 provides no such date of determination. Since no date has been provided, one can assume that this protection will apply for the duration of the pandemic. 

While these bills have passed at their respective levels, they have yet to reach the Governor’s office. These variations will have to be resolved and identical bills passed before they reach that point. Yet unless there is a major shift in perspective in both the House and Senate, it appears that businesses and health care providers will have a considerable amount of protection from liability during the COVID-19 crisis. 

If you or a loved one has been impacted by poor standards of care at an Ohio nursing home, assisted living or long-term care facility, it is vital that you speak with and experienced nursing home attorney. Cowan & Hilgeman has recovered millions of dollars in compensation on behalf of clients who were failed by the people and companies that were supposed to protect them. Understanding the legislative landscape during such uncertain times requires a strong yet empathetic guide. Call (937) 222-2030 today to schedule your free online or phone consultation with one of our nursing home attorneys.

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10 Signs of Nursing Home Abuse or Neglect

NURSING HOME ABUSE

The decision to place your loved one in a nursing home is often an enormously emotional one. You are trusting perfect strangers with the care and well-being of an important family member, hoping that trained nursing staff can provide them with the best quality of life possible. Thoroughly researching care facilities can reduce the chance that your loved one is mistreated, but even the most well-recommended nursing homes can hide a dark underbelly.

The frailty associated with old age can rapidly accelerate a decline in health and mental state, if the person in question is not properly cared for. Bed sores, in particular, can go from bad to life-threatening in only a few days, which is why it is vital that you remain vigilant in looking out for signs of nursing home abuse and neglect.

Here are the 10 most common signs of nursing home neglect, abuse and negligence:

1 – Dehydration

Elderly people do not feel thirsty in the same way that younger people do, especially when afflicted by Alzheimer’s or Dementia. Dehydration can turn lethal in only a few days, which is why nursing staff must constantly monitor patients’ fluid intake and output. If your loved one complains of being thirsty or frequent headaches, has a dry mouth or skin, or feels dizzy often, this can be a sign that they aren’t getting enough fluids.

2 – Weight Loss

Weight loss is common among new nursing home residents as they adjust to their new environment and food, but this should be actively monitored by doctors and nursing staff with the help of a nutritionist, if necessary. Meal plans should be adjusted to help bring your loved one back up to a healthy weight. Uncontrolled, untreated weight loss is a clear sign that the patient’s basic needs aren’t being met.

3 – Poor Personal Hygiene

Nursing homes that neglect their patients’ personal hygiene are generally obvious from the moment you walk in the door, but individual neglect is unfortunately quite common. If you notice that your loved one hasn’t been bathed as frequently as you would like, voice your concerns immediately to staff. If the problem is not quickly addressed, this can be a sign of more widespread abuse or neglect.

4 – Urinary Tract Infections

Frequent UTIs are a painful symptom of being improperly cared for. If your loved one is forced to wait to use the toilet until staff gets around to helping them, sitting in an adult diaper or soiled underwear for too long, being wiped incorrectly and bathed too infrequently are common reasons a urinary tract infection can develop. They can also be caused by dehydration.

5 – Slip and Falls

Unfortunately, elderly people are always at an increased risk of falling, but if you find that your loved one has fallen frequently or particularly severely, it is important that you find out how and why to prevent re-occurrence.

6 – Dirty clothing, bed clothes and living areas

If you notice odd or foul smells, dirty bed clothes, personal clothing items, overly full trash cans and uncleaned spills, notify staff immediately. Unsanitary conditions can lead to illness and disease, especially among the already frail and medically-compromised.

7 – Over-medication

Some nursing homes have been known to over-medicate their residents to make them more placid, controllable and easy to manage. While it is sometimes necessary to calm patients with Alzheimers or Dementia, psychotropic medication should rarely be used as a long-term treatment plan. If you find that your loved one is often unresponsive, uninterested and zoned-out, it is important to discuss their medication with their doctor. Always feel free to seek a second opinion.

8 – Inexplicable bruising

Elderly people have fragile skin that bruises easily, especially when taking medication to thin the blood. If you notice odd bruises that cannot be easily explained, such as bruises around the wrists or on the breasts/genitals, you may need to conduct a deeper investigation into their care.

9 – Bed Sores

Also known as pressure sores or ulcers, they should not be accepted as a common occurrence in nursing homes. They are always a sign that your loved one is being moved/turned too infrequently, and therefore neglected. Bed sores can go from bad to life-threatening very quickly, so they must be addressed immediately.

10 – Psychological issues

If your loved one becomes quiet, withdrawn, takes less pleasure in things that they are usually interested in, this can be a sign that their psychological state is being neglected. If they engage in self-soothing behaviors such as rocking back and forth, wrist-banging or head nodding, this can be an alarming sign of physical or emotional abuse.

If your loved one displays any of the above signs of nursing home neglect or abuse, fast action is of paramount importance. A diligent, caring nursing staff should take your concerns seriously and formulate a plan of action to address them immediately.

If staff fails to do that, if they try to tell you that you are imagining things or that these are a normal part of life in a nursing home, contact the experienced nursing home abuse attorneys at Cowan & Hilgeman.

There are strict deadlines to file a medical malpractice claim in Ohio, so do not delay in contacting a lawyer that has experience investigating nursing home medical malpractice claims.

The personal injury lawyers at Cowan & Hilgeman have recovered millions in compensation for clients. Our injury lawyers create plans of attack for each case tailored specific to the client’s needs and expectations.

The lawyers at Cowan & Hilgeman handle claims involving personal injury, medical malpractice, nursing home negligence, product liability and wrongful death. We routinely recover compensation on cases that other law firms reject.

Cowan & Hilgeman offers free personal injury case evaluations and only get paid an attorney fee if we win your personal injury case.
Call 937-222-2030 to get your free case evaluation.

Ohio Nursing Home Complaints

OHIO NURSING HOME COMPLAINTS

In a recent article written by Brandon Klein, Daily Reporter Staff Writer, for the July 12th, 2019 Issue of the Daily Court Reporter, Vol. 148-No.11, Ohio Ranked 21st in the country for nursing home complaints. Mr. Klein’s article, in its entirety, is provided below:

A new analysis shows that Ohio’s nursing homes are in the middle of the pack nationally based on the number of complaints per facility.

The Senior List ranked Ohio No. 21 based on most complaints per nursing home facility last year.

The state averaged 8.37 complaints per facility, costing its nursing homes $1.2 million in penalties from the Centers for Medicare & Medicaid Services, according to The Senior List’s “Which States Have The Best And Worst Nursing Homes” report.

The report based its findings on data from the Centers for Medicare & Medicaid Services’ 2019 report.

“The number of Americans residing in nursing care facilities has surged over the past half- century, rising more that 200-fold since the 1960s and nearly doubling in just the past 20 years,” the report stated. “As the U.S. population continues to grown older, it seems likely that more and more of us will require the care offered by nursing facilities in our later years because we need the kind of constant, skilled care such facilities offer.”

Washington had highest number of complaints at 18.1 per facility. Washington D.C. came in second at 15.56 complaints per facility, followed by Maryland (14.38), Nevada (13.52), New Mexico (13.26), Delaware (13), California (12.27), Alaska (12.11), Oregon (12.09) and Michigan (11.64).

New Hampshire had the lowest number of nursing home complaints. The state had 2.59 complaints per facility.

Alabama came in second at 3.16 complaints per facility, followed by Rhode Island (3.2), Tennessee (3.51), South Dakota (3.63), Mississippi (3.72), Georgia (3.89), New Jersey (4.12), Louisiana (4.45), Maine (4.69) and New York (4.78).

Nationally, 15,000 nursing homes had a total of 121,000 complaints or eight per facility, costing them $34 million in CMS penalties.

The most common complaint was the quality of care, which made up 19 percent of all complaints nationally, followed by resident rights (13 percent) and pharmacy services (12 percent).

Additionally, the report found:

  • Ohio ranked 16th for sub-standard care complaints with 1.01 such complaints per facility;
  • Ohio had the second lowest percentage of complaints of comprehensive, patient-centered care plans. Such complaints made up 6.1 percent and 21.3 percent in Vermont, the highest in the country;
  • And that Ohio ranked 34th for its percentage of 5-star nursing homes, which made up 19.4 percent of all of the state’s nursing facilities. On the other hand, Ohio ranked 10th for the percentage of 1-star nursing homes, which made up 22 percent of all facilities in the state.

“The choice of where a person spends what probably will be their final months and days on earth is an important one that they should be able to make in consultation with their physicians and families,” the report stated. “And knowledge is power; more and better oversight may well be needed, but families should use all the tools available to ensure the nursing facilities they and their family members use are focused not on maximizing profit but ensuring quality care, freedom and dignity of residents.”

The personal injury lawyers at Cowan & Hilgeman have recovered millions in compensation for our clients. Our lawyers create plans of attack for each case specific to the client’s needs and expectations. The lawyers at Cowan & Hilgeman handle claims involving personal injury, medical malpractice, nursing home negligence, product liability and wrongful death. We routinely recover compensation on cases that other law firms reject.

Cowan & Hilgeman offers free personal injury case evaluations and only get paid an attorney fee if we win your personal injury case.

Call 937-222-2030 to get your free case evaluation.

My family member got a bed sore (pressure ulcer) in a nursing home – what now?

My family member got a bed sore pressure ulcer in a nursing home – what now

Nursing home negligence and long-term care negligence can be seen in many forms. Unfortunately, victims of nursing home negligence and long-term care negligence are often unable to care for themselves. As family members of the aging population, we trust that nursing homes and long-term care facilities can properly care for our elderly family members and ensure their safety.

Typical indicators of nursing home negligence and long-term care negligence can be seen in the following cases:

  • A bed sore or pressure ulcers
  • Dehydration
  • Falls
  • Neglect
  • Abuse
  • Medication Errors
  • Conditions Resulting in Death

A bed sore – also called pressure ulcers and decubitus ulcers – are injuries to skin and underlying tissue resulting from prolonged pressure on the skin. A bed sore will most often develop on skin that covers bony areas of the body, such as the heels, ankles, hips, coccyx and tailbone.

What are the symptoms of a bed sore?

The Mayo Clinic notes that common warning signs of pressure ulcers are:

  • Unusual changes in skin color or texture
  • Swelling
  • Pus-like draining
  • An area of skin that feels cooler or warmer to the touch than other areas
  • Tender areas

What causes a bed sore?

According to Mayo Clinic, bed sores are caused by pressure against the skin that limits blood flow to the skin. Other factors related to limited mobility can make the skin vulnerable to damage and contribute to the development of pressure sores. The primary contributing factors for bedsores are:

  • Pressure – Constant pressure on any part of your body can lessen the blood flow to tissues. Blood flow is essential to delivering oxygen and other nutrients to tissues. Without these essential nutrients, skin and nearby tissues are damaged and might eventually die.

    For people with limited mobility, this kind of pressure tends to happen in areas that aren’t well-padded with muscle or fat and that lie over a bone, such as the spine, tailbone, shoulder blades, hips, heels and elbows.
  • Friction – Friction occurs when the skin rubs against clothing or bedding. It can make fragile skin more vulnerable to injury, especially if the skin is also moist.
  • Shear – Shear occurs when two surfaces move in the opposite direction. For example, when a bed is elevated at the head, you can slide down in bed. As the tailbone moves down, the skin over the bone might stay in place – essentially pulling in the opposite direction.

What are risk factors for bed sores?

People are at risk of developing bedsores if they lack mobility and are unable to easily change position. Risk factors include:

  • Cellulitis – Cellulitis is an infection of the skin and connected soft tissues. It can cause warmth, redness and swelling of the affected area. People with nerve damage often do not feel pain in the area affected by cellulitis.
  • Bone and joint infections – An infection from a pressure sore can burrow into joints and bones. Joint infections (septic arthritis) can damage cartilage and tissue. Bone infections (osteomyelitis) can reduce the function of joints and limbs.
  • Cancer – Long-term, nonhealing wounds (Majjolin’s ulcers) can develop into a type of squamous cell carcinoma.
  • Sepsis – Rarely, a bedsore leads to sepsis.

Are bed sores preventable?

Bedsores are preventable with adequate medical care. Bed sores can be prevented by:

  • Reducing pressure by the use of regular repositioning every 15 minutes to 2 hours.
  • Using support surfaces such as a mattress, bed and special cushions that help sit or lie in a way that protects vulnerable skin.
  • Adequate nutrition including hydration.
  • Early detection of bed sores which includes properly cleaning and dressing the wound.

If you or a loved one has been the victim of a bedsore or pressure ulcer, the injuries may be a result of medical negligence. There are strict deadlines to file a medical malpractice claim in Ohio, so do not delay in contacting a lawyer that has experience investigating bedsore medical malpractice claims.

The personal injury lawyers at Cowan & Hilgeman have recovered millions in compensation for clients. Our injury lawyers create plans of attack for each case tailored specific to the client’s needs and expectations.

The lawyers at Cowan & Hilgeman handle claims involving personal injury, medical malpractice, nursing home negligence, product liability and wrongful death. We routinely recover compensation on cases that other law firms reject.

Cowan & Hilgeman offers free personal injury case evaluations and only get paid an attorney fee if we win your personal injury case.
Call 937-222-2030 to get your free case evaluation.

Birth Injuries That Can Result from Medical Malpractice

Dayton Ohio Personal Injury attorney car accident birth injury lawyer - Jack Hilgeman - Cowan and Hilgeman

After the labor and delivery process, the last thing a mother wants to hear is that something is wrong with her baby.

Unfortunately, many birth injuries are caused by medical mistakes. If the doctor and other medical staff are careless in some way, the baby is at risk of getting severely hurt.

Let’s take a closer look at some of the most common birth injuries that can result from medical malpractice:

Facial Paralysis

If an infant’s face endures too much pressure during the delivery process, the face may become paralyzed. This type of injury is most common when doctors pull a baby out with forceps or a vacuum extraction. In many cases, this injury clears up in a few weeks. However, if the case is severe, the baby could suffer total paralysis on the side of the affected face.

Cephalohematoma

This injury causes bleeding under the cranium and usually shows up several hours after birth. The most obvious symptom of this injury is a bump at the top of an infant’s head. Although the bump will usually disappear in a few months, it can result in side effects, such as jaundice, anemia and hypotension.

Brachial Palsy Injuries

Infants can suffer brachial palsy injuries when the nerves responsible for moving the arms and hands are damaged. These injuries are most commonly caused by excessive stretching and force during delivery. Other causes include a breech delivery, large infant weight and maternal diabetes. Symptoms of brachial palsy injuries include a claw-like hand appearance, limited movement on the affected side and abnormal muscle contractions.

Brain Injuries

If a doctor does not carefully monitor a baby immediately after birth or leaves it in the birth canal too long, that infant can be deprived of oxygen and suffer brain injuries. These injuries can lead to severe consequences, such as chronic seizures, cerebral palsy and other intellectual and physical problems.

Fractures

Newborns can suffer fractures to the clavicle if the delivering doctors pulls on them too roughly while they are in the breech position. Infants with this injury typically can’t move the arm on the side of the fracture. Fortunately, these fractures generally heal in a little over a week.

Hiring a Medical Malpractice Attorney

If your baby suffered an injury during the delivery process because of the doctor’s negligence, you likely feel devastated and at a loss of what you should do. The first thing you should do is schedule a consultation with an experienced medical malpractice attorney. You may be entitled to compensation. A medical malpractice lawyer Washington D.C. residents rely on can assess the details of your case and determine if you have a good chance of winning a medical malpractice lawsuit or not. If the lawyer believes you have a strong case, he or she can help you gather necessary evidence, identify expert witnesses and represent you in court. You deserve justice for what happened to your baby during the delivery process.

Thanks to our friends and contributors from Cohen & Cohen, P.C., for their insight into medical malpractice.