BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 1250838 · Received November 25, 2008

    Report

    Report Number
    1218950-2008-00656
    Event Type
    Malfunction
    Date Received
    November 25, 2008
    Report Date
    October 28, 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
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE UNIT WOULD INTERMITTENTLY UNEXPECTEDLY SHUTDOWN. A PHILIPS FIELD SERVICE ENGINEER WENT TO THE CUSTOMER SITE AND EVALUATED THE UNIT. THE SYMPTOM WAS VERIFIED. REPLACEMENT OF THE BATTERY PCA RESOLVED THE REPORTED ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT WOULD INTERMITTENTLY UNEXPECTEDLY SHUTDOWN.

    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