BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX-EMS DEFIBRILLATOR

    MDR report key: 1853745 · Received October 1, 2010

    Report

    Report Number
    1218950-2010-01818
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Report Date
    September 2, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE UNIT HAD UNEXPECTEDLY SHUT DOWN. THE UNIT WAS EVALUATED AT THE PHILIPS (B)(6) REPAIR BENCH AND THE FAILURE COULD NOT BE RECREATED. AT THE DISCRETION OF THE REPAIR TECHNICIAN, MULTIPLE PARTS WERE REPLACED. WE WILL CONSIDER THIS REPORTED FAILURE A MALFUNCTION. WE CAN NOT DETERMINE THE CAUSE AS THE FAILURE COULD NOT BE RECREATED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT HAD UNEXPECTEDLY SHUTDOWN.

    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