BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRAGER

    MDR report key: 2901703 · Received January 3, 2013

    Report

    Report Number
    MW5028439
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    November 30, 2012
    Report Date
    December 19, 2012
    Manufacturer
    DRAEGER MEDIAL INC
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CITY WIDE POWER FAILURE OCCURRED AND VENTILATOR DID NOT CYCLE FROM AC TO BATTERY POWER. NURSE PROVIDED BAG MASK VENTILATOR TO PT AND NO HARM OCCURRED. NURSE DESCRIBED THAT VENTILATOR SCREEN WENT BLACK AND THE NURSE BELIEVED THE VENTILATOR WAS NOT DELIVERING BREATHS. THE VENTILATOR WAS REMOVED FROM SERVICE AND EVALUATED BY RESPIRATORY THERAPY. THE VENT HISTORY SHOWED THAT IT SWITCHED TO BATTERY POWER. UNABLE TO REPLICATE ERROR BY UNPLUGGING VENT, POSSIBLY DUE TO THE NATURE OF THE POWER OUTAGE. THE MFR ADVISED THAT THE CAUSE WAS LIKELY THE POWER SUPPLY UNIT WHERE THE AC TO BATTERY SWITCHOVER OCCURS. THE POWER SUPPLY HAS BEEN REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2965 DRAGER DRAGER VENTILATOR CBK DRAEGER MEDIAL INC EVITE 2 DURA

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening