People living with sleep apnea, asthma, and other conditions that make it difficult to breathe often rely on personal ventilators that they can use in their own homes. These personal medical devices should be safe to use and operate and should not cause additional harm or health problems to consumers. Unfortunately, this is not always the case.
On March 10, 2022, the U.S. Food and Drug Administration—the FDA—notified Philips Respironics that it is now required to clearly notify patients about its recalled ventilators. The Dutch medical equipment company initially recalled multiple breathing assistance machines and ventilators in June 2021, but many patients are still unaware of any potential hazards associated with their use.
Philips Respironics voluntarily recalled some of its devices because they contain polyester-based polyurethane foam, which is used to soften sounds and vibrations. This foam can degrade and break down, putting users at risk of swallowing or inhaling foam pieces or chemicals. If this happens, users can potentially:
- Suffer life-threatening injuries
- Suffer permanent impairment
- Need medical intervention
The FDA’s most recent action gives it leverage to require Philips Respironics to drastically improve its current communication efforts regarding the recall and the risk that the foam poses to patients, as prior efforts were deemed inadequate. This may be too little, too late for some users of Philips Respironics’ products, though.
When there is a dangerous medical device on the market, time is of the essence to prevent any further harm to public health.
At Frost Law Firm, PC, we know how upsetting it can be to learn that a medical device you or a loved one used was recalled. We rely on companies being honest and forthright about recalls, but many continue to prioritize their own bottom lines over the safety and well-being of their customers.
If you would like to talk about your legal options regarding a recalled or dangerous medical device, do not hesitate to contact us for a free evaluation. Our attorneys have 70 years of combined experience and are ready to put that knowledge and experience to work for you.