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Recall Observatory FDA recall evidence

Device product

Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.

Z-0827-2016

February 04, 2016

Class I

Product summary

Firm
Draeger Medical, Inc.
Event
Event 73241
Status
Terminated
Classification
Class I
Quantity
2553
Official record key
device-enforcement:Z-0827-2016

Official wording

Reason: The battery capacity of the optional PS500 power supply unit for the Infinity (ACS) Workstation Critical and Neonatal Care was rapidly and unexpectedly reduced, despite using the most recent power supply firmware version 1.50 released in November 2015 (recall Z-0436-2016). The batteries were prematurely discharged, even though an adequate battery charge status was displayed on the device.

Code information: Catalog #s 8416400 and 8417400

Distribution pattern: US Nationwide Distribution including Puerto Rico.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The battery capacity of the optional PS500 power supply unit for the Infinity (ACS) Workstation Critical and Neonatal Care was rapidly and unexpectedly reduced, despite using the most recent power supply firmware version 1.50 released in November 2015 (recall Z-0436-2016). The batteries were prematurely discharged, even though an adequate battery charge status was displayed on the device.