FDA MedWatch - Respironics California, Esprit V1000 and V200 Ventilators: Class I Recall - Power Failure May Occur

AUDIENCE: Risk Manager, Anesthesiologist, Surgeon

ISSUE: Respironics California Inc. has initiated a recall of Esprit V1000 and V200 Ventilators, Model V1000 and V200, installed with 3rd Generation Power Supplies, and 3rd Generation Power Supply Repair Part Kits. These devices were manufactured and distributed from December 21, 2012 to July 9, 2014.

The 3rd Generation Power Supplies are installed in Esprit V1000 and V200 Ventilators and are also sold as 3rd Generation Power Supply Repair Kits. A part in the 3rd Generation Power Supply may prevent the ventilator from using AC power (electricity from a wall socket) or may fail and prevent the ventilator from switching back to AC power after using battery power. Additionally, if a battery is not present or is used up, the ventilators will not work.

Failure of the power supply may cause the ventilator to shut off, which may result in too much carbon dioxide in a patient’s blood, not enough oxygen in the blood, or death.

There have been no reports of death or serious injury related to this potential problem.

BACKGROUND: The Esprit V1000 and V200 ventilators provide constant or periodic breathing help for adults and children, including newborns. These devices are used in hospitals and other health care settings.

RECOMMENDATION: A Philips field service engineer, trained service provider, or distributor will contact customers to schedule a replacement of the recalled 3rd Generation Power Supply with a 3.1 Power Supply on all Esprit V1000 and V200 ventilators, and all 3rd Generation Power Supply Repair Part Kits.

Philips Healthcare sent an URGENT Field Safety Notice dated September 17, 2014 to all customers who purchased the Esprit V1000 and V200 Ventilators.

The letter recommends that customers and users take these actions:

• Until the ventilator is replaced, it can still be used according to the directions for use. 
• If the power supply fails during use and the ventilator loses standard electrical current, a different ventilator must be used. 
• Be aware of the warnings from the Esprit V1000 and V200 operator’s manual. When lights and sound alarms occur, including a flashing red light when the battery is low, the patient must be supported by a different ventilator. 
Healthcare 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: www.fda.gov/MedWatch/report.htm 
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Read the MedWatch safety alert, including a link to the recall notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm423919.htm