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.
This recall has been terminated (originally issued December 23, 2015).
- Company
- Draeger Medical, Inc.
- Recall Initiated
- December 1, 2015
- Posted
- December 23, 2015
- Terminated
- April 3, 2020
- Recall Number
- Z-0436-2016
- Quantity
- 2422
- Firm Location
- Telford, PA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
US Nationwide-including DC and PR, and the states of AK; AR; AZ; CA; CO; CT; DE; FL; GA; HI; IA; ID; IL; IN; KS; LA; MA; MD; ME; MI; MN; MO; MS; MT; NC; ND; NE; NH; NJ; NM; NV; NY; OH; OK; OR; PA; SC; SD; TN; TX; UT; VA; VT; WA; WI; and WV.
Lot / Code Info
Catalog numbers: 8416400/8417400 distributed June 2011 October 2015.
Root Cause
Software design
Action Taken
Draeger Medical, Inc. sent an URGENT MEDICAL DEVICE RECALL letter dated November 2015 to all affected consignees. The letter identified the product, problem, and actions to be taken by the customers. The Battery Charging Software will be updated and, if necessary, the batteries replaced in all affected devices Free of Charge.