Recall – Perseus A500 Anesthesia Machine

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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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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