BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPAQ MD DEFIBRILLATOR

    MDR report key: 3883921 · Received February 13, 2014

    Report

    Report Number
    1220908-2014-00317
    Event Type
    Malfunction
    Date Received
    February 13, 2014
    Date of Event
    January 15, 2014
    Report Date
    January 30, 2014
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    LDD
    PMA / PMN Number
    K100654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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 WHILE ATTEMPTING TO TREAT A PATIENT THE DEVICE INAPPROPRIATELY SHUT DOWN. COMPLAINANT INDICATED THAT THE DEVICE POWERED BACK ON AFTER THE FOURTH ATTEMPT AND CONTINUED TREATING THE PATIENT. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95998 PROPAQ MD DEFIBRILLATOR DEFIBRILLATOR/PACEMAKER LDD ZOLL MEDICAL CORPORATION PROPAQ MD NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK