Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500), Evita V500 and /or

FDA device recall Z-1298-2014 · posted 2014-03-28 · Terminated

Recall details

Recalling firm

Draeger Medical Systems, Inc.

Reason for recall

The battery capacity of the optional PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected.

Action taken

Drager sent an Urgent Medical Device Recall letter dated February 2014. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to use an affected device for patient transport only if absolutely necessary; not to rely on the battery charge status indicator, always supervise the patient and the ventilator during transport; ensure that they have a manual breathing bag available for manual ventilation as recommended in the instructions for use. If the power fail alarm occurs during transport, immediately provide manual ventilation and connect ventilator to a wall power source to resume ventilation. DragerService representative will schedule the implementation of a permanent solution as quickly as possible. The letter should be distributed to users of the Evita V500 and /or Babylog VN500 Ventilators to make them aware of this device behavior and risk mitigation measures. Customers with questions were instructed to call 1-800-543-5047. For questions regarding the operation and/or servicing of their Draer ventilator contact Technical Support at 1-800-543-5047. For questions regarding this recall call 215-721-5400.

Root cause

Component design/selection

Status

Terminated

Product code

CBK

Quantity affected

1544

Distribution

Nationwide Distribution

Date initiated

2014-02-07

Date posted

2014-03-28

Date terminated

2015-08-17

Location

Telford, PA

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