BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX-EMS DEFIBRILLATOR

    MDR report key: 1032294 · Received April 21, 2008

    Report

    Report Number
    1218950-2008-00231
    Event Type
    Malfunction
    Date Received
    April 21, 2008
    Report Date
    March 25, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACTORY HAS NOT YET RECEIVED THE DEVICE FOR EVALUATION, AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE INTERMITTENTLY FAILED THE PACER TEST.

    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