BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 1122326 · Received August 15, 2008

    Report

    Report Number
    1218950-2008-00444
    Event Type
    Malfunction
    Date Received
    August 15, 2008
    Report Date
    July 16, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT FAILED THE PADS DEFIB TEST DURING OPCHECK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1