FDA MedWatch - All V60 and V60 Plus Ventilators by Philips Respironics:

U.S. Food and Drug Administration sent this bulletin at 06/07/2022 11:20 AM EDT

If your email program has trouble displaying this email, view as a webpage.

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

TOPIC: All V60 and V60 Plus Ventilators by Philips Respironics: Class I Recall - Due to Power Issue that May Cause Ventilator to Stop with or without Alarms

AUDIENCE: Patient, Health Professional, Risk Manager, Pulmonology

ISSUE: 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 power fluctuation causes a reboot of the backup alarm controller, which may lead to a complete shutdown of the ventilator without warning.

Affected ventilators may cease ventilation either with or without alarms. Such failures may lead to patients being deprived of oxygen for an extended time, which could cause serious adverse health consequences and death.

As of April 14, 2022, there have been reports of 4 injuries and 1 death associated with the use of the recalled devices.

For more information and detailed instructions about this recall, click on the red button "Read Recall" below.

BACKGROUND: The Philips Respironics V60 and V60 Plus ventilators are intended to support patient breathing. They are used to provide mechanical ventilation for adults and children who can breathe on their own, for example those with respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea.

RECOMMENDATIONS: On March 14, 2022, Respironics California, LLC, issued an Urgent Medical Device Correction to all affected consignees. The firm advised customers to keep the affected Philips V60 and V60 Plus ventilators in service and use them in accordance with the instructions for use and the following guidance:

Connect the Philips Respironics V60/V60 Plus to a nurse call/remote alarm system.
- Verify the operation of any nurse call/ remote alarm device before connected to the ventilator.
- Respond to all alarms.
Install an oxygen analyzer/monitor.
Provide pulse oximetry to inform the clinician of a change in the patient's condition.
Ensure access to an alternative ventilation device.
If a Philips Respironics V60/V60 Plus ventilator experiences a shutdown,
- Disconnect the patient, and
- Immediately start ventilation with an alternate device.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report online.
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

Follow us on Twitter at @FDAMedWatch

Manage Subscriptions | Unsubscribe All | Help