BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSMART MRX-EMS DEFIBRILLATOR

    MDR report key: 1193166 · Received October 7, 2008

    Report

    Report Number
    1218950-2008-00537
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Report Date
    September 23, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PARAMEDIC

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE UNIT FAILED TO POWER UP. THE FACTORY HAS NOT YET RECEIVED THE DEVICE FOR EVALUATION, AND THE COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT FAILED TO POWER UP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1