BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPAQ MD DEFIBRILLATOR

    MDR report key: 2831455 · Received October 11, 2012

    Report

    Report Number
    1220908-2012-02864
    Event Type
    Malfunction
    Date Received
    October 11, 2012
    Report Date
    September 18, 2012
    Manufacturer
    ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS
    Product Code
    LDD
    PMA / PMN Number
    K100654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORP HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A FOLLOW-UP REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE HAD AN UNSPECIFIED PACER PROBLEM. COMPLAINANT INDICATED THAT THERE WAS NO PT INVOLVEMENT IN THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROPAQ MD DEFIBRILLATOR DEFIBRILLATOR/PACEMAKER LDD ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS PROPAQ MD NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA