FDA Recall of All Philips V60 and V60 Plus Ventilators
The U.S. Food and Drug Administration (FDA) has announced that a voluntary recall notice for Philips Respironics V60 and V60 Plus ventilators due to the possibility of ventilator failure. The recall has been categorized as a Class I recall and affects all models of Philips V60 and V60 Plus product lines. A Class I recall is the highest level of recall and indicates that serious injury or death may occur if the device fails to function as intended.
Philips Ventilator May Stop Due to Power Fluctuation
Philips Respironics ventilator failure may be caused by internal power fluctuation which cause the V60 family ventilators to shut down unintentionally. The power fluctuation may begin with the electrical circuit that controls the 35-volt power supply to the ventilator and its alarm.
The shutdown may occur, either with or without visible or auditory alarm. Power fluctuation in the ventilator may also cause a reboot of the backup alarm controller, leading to a complete shutdown without warning.
Failure of a ventilator may lead to loss of oxygen flow for long periods of time. This may result in serious harm or death for the patient. At least 4 injuries and 1 death have been associated with use of the recalled Philips V60 ventilators.
Philips Respironics V60 Device Use
Philips Respironics V60 and V60 Plus ventilators are used to provide mechanical ventilation or support breathing. They are assist ventilators intended to augment breathing and are not intended to function as a life support ventilator.
Philips V60 ventilators are used in adults and children who are able to breathe on their own who may require support, most commonly in those with respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea disorders.
Philips V60 and V60 Plus Ventilators are used in institutional settings such as hospitals, under the supervision of health care professionals. The ventilators are not authorized for use in home settings or non-institutional settings. Facilities, health care professionals and patients should be made aware of the recall notification.
Philips Respironics V60 and V60 Plus Recall Instructions
Philips Respironics V60 and V60 Plus Ventilator Class I recall warning notification issued by the FDA in April 2022, includes measures that should be taken for all models of the device but does not recommend that ventilators be removed from use.
The warning advised that V60 ventilators could be kept in service if certain guidance measures are followed, and the device is used according to instructions. Institutions using the ventilators should:
- Connect device to a nurse call or remote alarm system to provide backup notification if device alarm fails
- Install oxygen analyzer or monitor on the device
- Provide pulse oximetry for patient monitoring
- Ensure access to alternative ventilation devices
In the event of device failure, health care professionals are advised to disconnect the device and transfer patient ventilation to alternate device.
Philips Respironics V60 Ventilators Prior Recalls
The April 2022 recall involving Philips V60 ventilators is only the latest in a series of issues involving Philips Respironics. Philips had issued a prior notification in March 2022 involving the same V60, V60 Plus and V680 devices but has had a number of issues with other products.
Past recalls have included CPAP and BiPAP machines from the DreamStation line and others including A and C Series, Dorma, SystemOne, and Trilogy ventilators. The company is already facing numerous lawsuit claims for CPAP and BiPAP machines and may be facing additional lawsuits for the V60 ventilator power supply issues.
Philips Respironics V60 and V60 Plus Ventilator Lawsuit
At least four serious injuries and one death have already been associated with the Philips V60 power supply failure issue. Though health care institutions have been advised to ensure that additional monitoring and notification methods are in place and that alternative ventilation be available if the device should fail, patients may still be at risk.
Use of the devices which have demonstrated potential failure may continue to leave patients at risk of oxygen deprivation, particularly in facilities or locations which do not have appropriate systems in place or cannot provide additional equipment and monitoring.
People or loved ones of those who experienced harm or were placed at risk due to potential failure of a Philips Respironics V60 or V60 Plus Ventilator may be eligible for compensation.