More than 105,000 medical device reports were sent by the breathing machine manufacturer Phillips to the Food and Drug Administration (FDA) between April 2021 and June 2023. Manufacturers are required to submit these reports, known as MDRs, if there is evidence “that reasonably suggests that one of their devices may have caused or contributed to a death or serious injury, or has malfunctioned and that device or a similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur,” stated the FDA. In the case of Phillips’ breathing machines, such events included 385 reports of death linked to the PE-PUR foam breaking down.
A Redesign Gone Wrong
In 2010, Philips Respironics redesigned the breathing machines after receiving consumer complaints that the products were too loud and kept them up at night. To make the products quieter, they used sound abatement foam, similar to what is used in furniture like sofas.
Following the redesign, Phillips began to receive complaints of “dirt and dust”, “oily substances”, and “contamination” inside the machines meant to help patients that were having difficulty breathing. ProPublica reported that many of those complaints were kept from the FDA “even as their numbers grew from dozens to hundreds to thousands”.
Phillips initiated a voluntary recall in June 2021, more than a decade after the initial complaints surfaced. The company said it discovered a potential connection between the foam in various CPAP, BiPAP, and Mechanical Ventilator devices and certain injuries to consumers. In the recall, the manufacturer acknowledged that the foam had the potential to crumble when exposed to heat and humidity and that the potentially carcinogenic particles could make their way into a patient’s nose, mouth, throat, and lungs.
Patients Die As Phillips Profits Soar
An investigation by ProPublica and Post-Gazette analyzed more than 3,700 complaints submitted to the FDA over eleven years. The investigation revealed that Phillips did not institute a formal investigation of patient injuries and deaths linked to their medical devices until nine years after initial complaints were made. Following the recall, Phillips doubled down on their marketing efforts and claimed that tests administered on their best-selling DreamStation and other similar devices showed that the chemicals released by the machines fell within safety thresholds.
What CPAP Machines Are Part of the Recall?
Eighty percent of the devices involved in the recall are Continuous Positive Airway Pressure (CPAP) machines used by individuals to help with sleep apnea, as reported to Reuters by company spokesman Steve Klink. The following Phillips devices were included in the recall initiating a nationwide recall affecting millions:
- DreamStation ASV (Also known as DreamStation BiPAP autoSV)
- DreamStation ST, AVAPS (Also known as DreamStation BiPAP AVAPS, DreamStation BiPAP S/T)
- SystemOne ASV4 (Also known as System One BiPAP autoSV, System One BiPAP autoSV Advanced)
- C Series S/T, AVAPS (Also known as System One BiPAP AVAPS (C-Series), System One BiPAP S/T (C-Series)
- OmniLab Advanced Plus (In-Lab Titration Device)
- System One 50 series (CPAPs, Auto CPAP, BiPAPs)
- System One 60 series (CPAPs, Auto CPAP, BiPAPs)
- DreamStation CPAP, Auto CPAP, BiPAP
- DreamStation GO CPAP, APAP, Auto CPAP
- Dorma 400, 500 CPAP, Auto CPAP (not marketed in the US)
- Trilogy 100 Ventilator
- Trilogy 200 Ventilator
- Garbin Plus, Aeris, LifeVent Ventilator (not marketed in the US)
- A-Series BiPAP Hybrid A30 (Also known as BiPAP Hybrid A30Ventilator A-Series – not marketed in the US)
- A-Series BiPAP V30 Auto Ventilator (Also known as BiPAP V30 Auto Ventilator – A-Series)
- A-Series BiPAP A40 (Also known as BiPAP A40 Ventilator A-Series – not marketed in the US)
- A-Series BiPAP A30 (Also known as BiPAP A30 Ventilator A-Series – not marketed in the US)
If consumers are unsure if their device is affected, they may check their device’s serial number at www.usa.philips.com/healthcare/e/sleep/communications/src-update. Users and caregivers may also call 877-907-7508.
Call An Experienced Product Liability Attorney
The FDA has documented an alarming tally of more than a hundred tragic incidents connected to Philips’ CPAP machines, with countless others left grappling with severe injuries. These individuals, driven by trust in the safety of these respiratory devices, found themselves facing a harsh reality of suffering, sickness, and even tragic loss, rather than the relief they had hoped for.
The attorneys of Panter, Panter, and Sampedro have the expertise and resources needed to get just compensation for the losses suffered due to defective products and devices such as Philips’ respiratory devices. Our team of expert attorneys can help you understand your options and navigate the legal process. Call (305) 662-6178 and speak to an experienced product liability attorney today.
*On March 24, 2023, Governor Ron DeSantis signed House Bill (HB) 837 reducing Florida’s statute of limitations for general negligence cases from four years to two years. In other words, a lawsuit alleging negligence must now be filed within two years of the date of the alleged negligence or the claim will be forever barred.