BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPAQ MD DEFIBRILLATOR

    MDR report key: 3842579 · Received February 24, 2014

    Report

    Report Number
    1220908-2014-00416
    Event Type
    Malfunction
    Date Received
    February 24, 2014
    Date of Event
    February 8, 2014
    Report Date
    February 10, 2014
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    LDD
    PMA / PMN Number
    K100654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION 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 PACE A 50 YR OLD FEMALE PT, THE DEVICE FAILED TO CAPTURE THE PTS HEART RHYTHM. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PT DUE TO THE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112233 PROPAQ MD DEFIBRILLATOR PROPAQ MD LDD ZOLL MEDICAL CORPORATION PROPAQ MD NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR