BEUDAMED
    FDA Adverse Event Other Summary report: N

    DRAEGER EVITA 4 NEOFLOW

    MDR report key: 1410802 · Received July 1, 2009

    Report

    Report Number
    MW5011720
    Event Type
    Other
    Date Received
    July 1, 2009
    Date of Event
    June 8, 2009
    Report Date
    July 1, 2009
    Manufacturer
    DRAEGER MED INC./EVITA 4
    Product Code
    CBK
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RN STATED SHE HEARD A LOUD POP AND SCREEN WENT BLANK, SMELLED OF HOT ELECTRICAL. RN GAVE PPV, VENT CHANGED OUT FOR DIFFERENT ONE. INFANT TOLERATED PPV WELL. AFTER VENTILATOR PULLED, NEW EMPLOYEE PULLED CIRCUIT OF VENT AND DISPOSED OF. PLUGGED VENT BACK IN AND ALARMING AUDIBLY AND SCREEN BLACK. USER ERROR. COMPANY DID COME IN AND CHECK MACHINE. PROBLEM WITH VALVE ATTACHED TO UNIT. MISSING DRAIN BOTTLE RESULTING IN FAILURE. PERFORMED 6 MONTH PM. PERFORMANCE TEST PASSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAEGER EVITA 4 NEOFLOW VENTILATOR CBK DRAEGER MED INC./EVITA 4 EVITA

    Patients

    Seq Age Sex Outcome Treatment
    1 26 DA