Company: Respironics California Inc. (a division of Philips Healthcare)
Date of Enforcement Report 11/19/2014
Class I:
Date Recall Initiated: September 17, 2014
PRODUCT
Esprit V1000 and V200 Ventilators, Model V1000 and V200, Installed with 3rd Generation Power Supplies, and 3rd Generation Power Supply Repair Part Kits ? See complete listing of serial numbers.
Manufactured and Distributed from December 21, 2012 to July 9, 2014
Use: 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.
REASON
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..
RECALLING FIRM/MANUFACTURER
Respironics California Inc. (a division of Philips Healthcare), Carlsbad, CA on 9/17/2014. Voluntary: Firm Initiated recall is ongoing.
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