CompanyDraeger Medical, Inc.
Date of Enforcement Report 6/27/2018
Class lI:
PRODUCT
Perseus A500 Anesthesia Machine; Cat. no. MK06000Product VProduct Usage:Intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pressuresupported spontaneous breathing, and spontaneous breathing. Perseus is equipped with airway monitoring, gas measurement and device monitoring,
Recall Number: Z-2254-2018
REASON
The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC module would not prevent setting an N2O flow that would result in a hypoxic mixture from being dosed to the patient. Potential adverse outcomes include death of the patient.
RECALLING FIRM/MANUFACTURER
Draeger Medical, Inc., Telford PA. on 5/24/2018. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
33
DISTRIBUTION
Nationwide
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