BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 1250912 · Received December 2, 2008

    Report

    Report Number
    1218950-2008-00670
    Event Type
    Malfunction
    Date Received
    December 2, 2008
    Report Date
    November 3, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S REPORTED THAT THE UNIT KEEPS REBOOTING. PHILIPS EVALUATED THE UNIT AND VERIFIED THE FAILURE. REPLACING THE INTERNAL DATA CARD RESOLVED THIS ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT KEEPS REBOOTING.

    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