BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 1250835 · Received November 25, 2008

    Report

    Report Number
    1218950-2008-00652
    Event Type
    Malfunction
    Date Received
    November 25, 2008
    Report Date
    October 29, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THEY HAD INTERNAL MEMORY CARD FAILURE MESSAGES WITH ASSOCIATED REBOOTING OF THE DEVICE. THE DEVICE WAS EVALUATED AT PHILIPS, AND THE INTERNAL MEMORY CARD FAILURE WAS CONFIRMED; THE REBOOT SYMPTOM COULD NOT BE REPRODUCED. REPLACING THE INTERNAL MEMORY CARD RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY HAD INTERNAL MEMORY CARD FAILURE MESSAGES WITH ASSOCIATED REBOOTING OF THE DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1