Draeger Optional PS500 Power Supply Unit Cl II

Company: Draeger Medical, Inc.
Date of Enforcement Report 12/30/2015
Class lI:

PRODUCT

Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN500 Ventilator. Babylog VN500 is a ventilation unit intended for the ventilation of neonatal and pediatric patients. Recall Number Z-0436-2016

REASON
The firm became aware of cases in which the battery run times of the optional PS 500 power supply unit with the Infinity Workstation Critical Care (Evita Infinity V 500) were unexpectedly short due to the design of the charging algorithm in the current software. Devices used for patient transport will be a priority.

RECALLING FIRM/MANUFACTURER
Draeger Medical, Inc., Telford, PA on 12/1/2015. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
2422

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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