In a recent development dated June 28, 2024, a Philips spokesperson, Lu Yu, issued a statement contending the numbers of reported injuries and deaths cited by the FDA notice a day earlier regarding their bilevel positive airway pressure (BiPAP) machines, namely the A30 and A40 models. Philips acknowledges receiving reports of 10 serious injuries and seven deaths linked to these models over a span from 2011 to 2023 but states there have been no reports of serious harm with the V30 model.
On the other hand, the FDA reported that the recall of these Philips BiPAP machines is associated with 952 injuries and 65 deaths. This stark discrepancy in reported figures between Philips and the FDA has raised concerns about the safety and reliability of these devices.
Initially, Philips began recalling its V30, A30, and A40 BiPAP machines in March following an issue with a false alarm that could cause the machines to shut down unexpectedly. Despite this critical concern, Philips updated the usage instructions rather than removing the devices from the market or discontinuing their sale. In response to the situation, the FDA officially posted this recall in their database in May, noting that there had been 10 injury reports and seven deaths at the time—an increase which Philips has not fully addressed publicly as of yet.
Philips spokesperson Ben Zwirs later clarified that the recall impacts about 100,000 units. He explained that under certain conditions, the devices’ ventilator inoperative alarm might incorrectly trigger, resulting in the ventilator shutting down. He assured that Philips was actively investigating these incidents and would take appropriate measures based on their findings. The company’s newly updated instructions advised that if an alarm occurs, the patient should be switched to an alternative device immediately. Moreover, if any interruptions to the therapy are potentially life-threatening, patients and caregivers should use an alternate ventilation source and contact their equipment supplier for an immediate alternative solution.
Philips appears to be in a contentious phase regarding its sleep and respiratory care products in the U.S. Following a consent decree with the Department of Justice and the FDA earlier in the year, sales of many of Philips’ sleep and respiratory products in the U.S. have been restricted. This is not the first instance of recall for their BiPAP machines. There were earlier recalls in 2022 due to contamination issues with the plastic used in the machines and in 2021 due to the breakdown of soundproofing foam that posed a risk of being inhaled by users.
The products in question, the V30 machines, are utilized in institutional or hospital settings mainly in the U.S. and are designed to treat adults and children with obstructive sleep apnea and respiratory insufficiency. Meanwhile, the A30 and A40 Pro ventilators, which have now come under scrutiny, are meant for both home and clinical use and have been predominantly sold outside the U.S.
Though Philips assures that it is taking the FDA’s findings seriously and is engaged in ongoing discussions with the agency, the significant difference in injury and death reports linked to their products raises questions about the potential risks posed to patients. This situation underscores the importance of rigorous device safety monitoring and effective communication between manufacturers, regulatory bodies, and the public to ensure patient safety. Further updates and specific actions from Philips are anticipated as the company continues to address and rectify these critical safety concerns.
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