BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEFIBRILLATOR

    MDR report key: 2601627 · Received May 31, 2012

    Report

    Report Number
    MW5025657
    Event Type
    Other
    Date Received
    May 31, 2012
    Date of Event
    March 5, 2012
    Report Date
    May 2, 2012
    Manufacturer
    MEDTRONIC PHYSIO CONTROL
    Product Code
    MKJ
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ALARMS FOR HEART RATE, SPO2, AND VF/VT ARE SET TO OFF UPON POWERING UP THE DEFIBRILLATION. FACTORY DEFAULT SETTING. THE FACTORY DEFAULTS FOR ALL OF OUR NEW DEFIBRILLATORS IN THE ALARMS FOR HEARTRATE, SPO2, AND VF/VT ARE SET TO OFF. THIS IS AN IMPORTANT ALARM IF YOU ARE MONITORING A PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEFIBRILLATOR NONE MKJ MEDTRONIC PHYSIO CONTROL LIFEPAK 20E 99507-000002

    Patients

    Seq Age Sex Outcome Treatment
    1