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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Software Verification

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Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.