BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 1930528 · Received November 30, 2010

    Report

    Report Number
    1218950-2010-02390
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Report Date
    November 1, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE UNIT FAILED TO RECOGNIZE THE BATTERY IN BAY "B". THE UNIT FAILED TO STAY POWERED UP WHEN THE UNIT WAS ON BATTERY POWER FROM THE "B" BAY. THIS COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT FAILED TO RECOGNIZE THE BATTERY IN BAY "B". THE UNIT FAILED TO STAY POWERED UP WHEN THE UNIT WAS ON BATTERY POWER FROM THE "B" BAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX - EMS DEFIBRILLATOR MKJ PHILIPS HEALTHCARE M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1