BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX-EMS DEFIBRILLATOR

    MDR report key: 1924973 · Received November 22, 2010

    Report

    Report Number
    1218950-2010-02342
    Event Type
    Malfunction
    Date Received
    November 22, 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
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE AC POWER MODULE FAILED. A PHILIPS FIELD SERVICE ENGINEER WAS AT THE CUSTOMER SITE. THE AC POWER MODULE WAS TESTED AND THE FAILURE WAS VERIFIED. REPLACEMENT OF THE MODULE RESOLVED THE FAILURE. THE UNIT PASSED ALL POST-SERVICING TESTING. THE UNIT REMAINS AT THE CUSTOMER SITE WITH THE NEW MODULE INSTALLED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE AC POWER MODULE FAILED.

    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