The U.S. Food and Drug Administration (FDA) has issued a Class I recall regarding the Philips Respironics V60 and V60 Plus Ventilator models. The recall notice issued June 7 states that the use of these devices could result in serious injury or death.
The Philips Respironics V60 and V60 Plus ventilators are medical devices that are supposed to assist patients in breathing. Ventilators are used on adults and children in the event of respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea. The FDA states that ventilators are medical equipment most commonly used in hospitals and designed to be operated under the supervision of medical professionals.
Philips has already faced a recall of these models in March after it was discovered that some of the V60 and V60 Plus units were assembled with a faulty adhesive, leading to power failure.
In the current recall, the FDA explains that “Philips Respironics is recalling all V60 and V60 Plus ventilators because an internal power fluctuation may cause the ventilator to shut down unintentionally either with or without any visible or audible alarms.” The nature of the power fluctuations causes a reboot of the backup alarm controller, which can shut down the ventilator completely without prior warning.
The recall targets 49,680 V60 devices and 6,991 V60 Plus devices for a total of 56, 671 devices manufactured and distributed between May 1, 2009, and December 22, 2021. The FDA warns that should these affected devices be left in circulation, they may stop functioning without alarm, leading patients to suffer from oxygen deprivation, a potentially fatal complication. According to the FDA, “As of April 14, 2022, there have been reports of 4 injuries and 1 death associated with the use of the recalled devices.”
In addition to the recall notice, the FDA has included some steps that can be taken to increase patient safety in the event that an affected device is being used to treat patients. These safety steps include:
- Connecting the affected device to an external nurse call or remote alarm system that has been verified to work.
- Immediately responding to high-priority alarms and responding quickly to low-quality alarms from the device.
- Installing an oxygen monitor or analyzing device.
- Providing pulse oximetry in order to inform staff of changes in the patient's condition.
- Ensuring an alternative ventilation device is always immediately accessible.
Following these steps may help keep patients stable while a replacement unit is on its way.
Philips Respironics has received a large amount of public attention over the safety of its ventilators. In 2021, Philips faced a class action lawsuit over health complications caused by foam degradation in its continuous positive airway pressure (CPAP) machines. In May, the FDA released a guide to recalled Philips Respironics devices to help guide consumers.