BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 1163406 · Received September 10, 2008

    Report

    Report Number
    1218950-2008-00492
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Report Date
    August 12, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED AFTER THE DEVICE HAS BEEN RECEIVED BY PHILIPS FOR EVAL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT FAILED TO POWER UP VIA AC OR BATTERY POWER.

    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