Philips Responics A-series of ventilators

2023: Philips defective breathing equipment receives 100,000 complaints amid recall of millions of devices

On February 9, 2023, Philips released new information relating to a high-profile scandal involving the company's defective breathing devices. We are talking about potentially dangerous devices for the therapy of snoring and apnea, as well as other devices supplied to the market by a subsidiary of Philips Respironics.

As it turned out, defective equipment used sound-absorbing foam, which could theoretically decompose and enter the respiratory tract. In this regard, in June 2021, the manufacturer initiated a large-scale recall program, under which about 5.5 million devices fell.

Philips defective breathing equipment receives complaints

Now it is reported that the US Food and Drug Administration (FDA) has received a total of almost 100 thousand complaints about defective Philips Responics devices. In these documents, in particular, approximately 260 deaths are mentioned. According to Philips, about 20,500 Medical Device Report (MDR) reports were sent to the FDA between April 2021 and April 2022. Over the next six months - until October 2022 - approximately 70,500 complaints were filed, and in November and December 2022 - another 8300. Thus, the total number of reports exceeded 99,000.

Importantly, the MDR submission itself is not evidence that the device caused any undesirable event or contributed to an unfavorable outcome. Based on the investigations conducted, Philips Responics did not find convincing data linking defective devices and deaths recorded in some of the reports. Philips Responics investigates all claims of technical malfunctions, serious harm to health or deaths, the company said in a statement.[1]

2022: Launch of a new recall of defective ventilators

On August 30, 2022, Philips announced the expansion of the recall of its artificial lung ventilation devices, which was a continuation of the recall, which began in April 2021.

The FDA issued a notice warning patients, caregivers and service providers that some Philips Respironics devices with two-level positive airway pressure (BiPAP or BPAP) may contain plastic made up of toxic materials. If such plastic is in the body of the apparatus, it can release certain volatile organic compounds. It can also cause the machine to fail and suddenly stop working during use, which can lead to serious injury or death.

Philips launched a new recall of defective ventilators

The FDA said the potential risk of inhaling volatile organic compounds includes headache, dizziness, irritation of the eyes, nose, airways and skin, hypersensitivity, nausea or vomiting, and a poisoning and cancer-causing effect.

Philips Respironics did not receive reports of cases of harm to patients as a result of this problem, but decided to expand the recall to prevent similar cases from occurring in the future, a Philips spokesman said.

Between August 6, 2020 and September 1, 2021, Philips distributed 386 affected BiPAP machines in the United States. On August 26, 2022, the company notified affected customers by letter of an urgent recall of the medical device. Reuters reports that the recall affected 1,700 devices around the world.

The feedback affected the following devices:

• A-Series BiPAP A30
• A-Series BiPAP A40
• A-Series BiPAP V30
• OmniLab Advanced+

The A-Series BiPAP A30 and A-Series BiPAP A40 devices were also among those affected during the recall in June 2021. No action is required if such a device has been fixed or replaced during the June 2021 recall procedure, as the affected plastic components have also been replaced, the FDA said in a notice.^[2][3][4]

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