BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 1781303 · Received July 28, 2010

    Report

    Report Number
    1218950-2010-01242
    Event Type
    Malfunction
    Date Received
    July 28, 2010
    Report Date
    June 28, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED INTERMITTENT POWER ISSUES WITH THE AC POWER MODULE. THE UNIT WAS EVALUATED AT PHILIPS AND THE REPORTED FAILURE COULD NOT BE VERIFIED. AT THE DISCRETION OF THE REPAIR TECH MULTIPLE PARTS, INCLUDING THE AC POWER MODULE, WERE REPLACED. WE WILL CONSIDER THIS FAILURE A MALFUNCTION, ALTHOUGH WE CANNOT DETERMINE THE CAUSE, AS THE FAILURE COULD NOT BE RECREATED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED INTERMITTENT POWER ISSUES WITH THE AC POWER MODULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX MKJ PHILIPS MEDICAL SYSTEMS M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1