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Recall Observatory FDA recall evidence

Device product

Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500), Evita V500 and /or Babylog VN500 Ventilators, used for ventilation during short term transport of patients within a hospital.

Z-1298-2014

February 07, 2014

Class I

Product summary

Firm
Draeger Medical Systems, Inc.
Event
Event 67502
Status
Terminated
Classification
Class I
Quantity
1544
Official record key
device-enforcement:Z-1298-2014

Official wording

Reason: 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.

Code information: all lots

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.