United States
Royal Philips (NYSE: PHG, AEX: PHIA), today announced that its subsidiary Philips Respironics is notifying customers of its V60/V60 Plus and V680 ventilators about a potential issue with the electrical circuit in these ventilators that controls the 35V power supply to the ventilator and alarm. Philips Respironics has identified that there is a possibility that affected ventilator units may cease to operate, potentially without setting off an audible/visual alarm (a so-called silent shutdown), and the patient may no longer receive respiratory assistance.
Philips Respironics projects an average of less than one silent shutdown among one million uses per year. Philips Respironics is advising customers that they must implement one or more of the following actions to mitigate the rare possibility of the hazard caused by the 35V electric circuit issue:
- Implement an oxygen analyzer with appropriate alarm settings for each V60/V60 Plus, or V680; and/or
- Connect the V60/V60 Plus or V680 to a nurse call/remote alarm system, as documented in the instructions for use; upon request, Philips Respironics can provide technical assistance to implement this nurse call/remote alarm capability; and/or
- Monitor the patient with pulse oximetry or other physiological monitoring appropriate to the institution’s capabilities and patient needs.
Additionally:
- An alternative means of ventilation should be available whenever the V60/V60 Plus or V680 ventilator is in use. If a fault is detected in the ventilator, disconnect the patient from it and immediately start ventilation with such an alternative device. The ventilator must be removed from clinical use and serviced by authorized service personnel.
If these mitigations are not available, Philips Respironics recommends each institution deliberately make a decision that balances the risks and benefits of continued use of the V60/V60 Plus and V680 against the risks and benefits of ceasing use and/or substituting other ventilators. Such decision-making should consider the institution’s capabilities and patient needs.
Philips Respironics is committed to addressing the issue and will provide regular updates to customers on the development of its plan to address the issue, with the first update to be provided before June 30, 2022. The V60/V60 Plus is not a life support ventilator. It is an assist ventilator and is intended to augment patient breathing. The V680 ventilator provides invasive and non-invasive respiratory support. The V60/V60 Plus and V680 ventilators are not authorized for use in a home or non-institutional setting.
Company name: Philips Respironics
Brand name: Philips Respironics
Product recalled: V60/V60 Plus, and V680
Reason of the recall: A potential issue with the electrical circuit in these ventilators that controls the 35V power supply to the ventilator and alarm
FDA Recall date: May 02, 2022
Source:
www.fda.gov
