BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 2023102 · Received February 15, 2011

    Report

    Report Number
    1218950-2011-00404
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Report Date
    January 18, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE BATTERY FAILED TO CHARGE. THERE WAS NO REPORT OF PT INVOLVEMENT. A PHILIPS INVESTIGATOR SPOKE WITH THE CUSTOMER WHO REPORTED THAT THE UNIT FAILED TO POWER UP ON BATTERY POWER. THE BATTERY WAS REPLACED UNDER WARRANTY WHICH RESOLVED THE FAILURE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE BATTERY FAILED TO CHARGE. THERE WAS NO REPORT OF PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX -EMS DEFIBRILLATOR MKJ PHILIPS HEALTHCARE M3536A 1029-184-P

    Patients

    Seq Age Sex Outcome Treatment
    1