FDA Recalls Ventilators For Adhesive Defect
The U.S. Food and Drug Administration (FDA) has issued a recall of ventilators made by Philips Respironics. The FDA notice, released on March 21, stated that Philips Respironics’ V60 and V60 Plus ventilators could stop functioning without warning or notification, potentially leading to patient deaths.
The Philips Respironics V60 and V60 Plus ventilators are a series of respiration aids used in hospitals and other medical facilities with professional-grade equipment and technician supervision. The devices are used to aid in the breathing of children and adults who are suffering from conditions that make breathing difficult such as chronic respiratory insufficiency, obstructive sleep apnea, and respiratory failure.
This recall was issued after it was discovered that some V60 and V60 Plus devices distributed between July 29, 2021 and August 11, 2021 were assembled with faulty materials. According to the FDA recall notice, over 1,500 of these ventilators were assembled with expired adhesive.
The expired adhesive causes a significant chance of failure. If the adhesive begins to fail, the capacitor support bracket it holds in place can become loose and damage the capacitors. This damage to the capacitors may cause the device to stop functioning. The FDA notice notes that this failure could be so subtle that it may not set off the device’s failure alarm.
The FDA has classified this recall as Class I, meaning that the use of these V60 and V60 Plus devices may lead to serious injury or death. “If ventilation stops and sounds an alarm, patients could be without ventilation support for the duration required for an alternate ventilator to be connected. If the ventilator does not sound an alarm when the ventilation stops, the patient could be deprived of oxygen for an extended time, which could cause serious adverse health consequences and death,” the recall notice states.
At the time of the notice’s release, the FDA has not received reports of injuries or deaths. Philips Respironics has sent an Urgent Medical Device Correction Notice to distributors and customers.
The notice instructed distributors and customers to:
- Compare device serial numbers to a list of impacted serial numbers provided by Philips to determine if a ventilator is impacted.
- Connect the ventilator to a remote alarm system to provide a backup alarm system.
- Provide external oxygen monitoring to minimize patient risk in the event of ventilator failure.
- Respond to all low priority and high priority alarms presented by the ventilator.
- Always have immediate access to an alternative means of ventilation.
Philips included information on what to do in the event that a V60 or V60 Plus were to experience this shutdown.
Philips Respironics is also facing lawsuits and recalls over their sleep apnea devices. The devices have been found by the FDA to have soundproofing foam that breaks down into respirable particles, allegedly leading to a number of adverse health effects.