BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD1200 DEFIBRILATOR/PACEMAKER

    MDR report key: 1981251 · Received February 1, 2011

    Report

    Report Number
    1220908-2011-00144
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 11, 2011
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    LDD
    PMA / PMN Number
    K873402
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL CORPORATION HAS RECEIVED THE PRODUCT AND WILL BE PROVIDING A F/U REPORT WHEN OUR INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A (B)(6) FEMALE PT, THE DEVICE FAILED TO CHARGE. COMPLAINANT INDICATED THAT THE PT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PD1200 DEFIBRILATOR/PACEMAKER DEFIBRILLATOR LDD ZOLL MEDICAL CORPORATION PD1200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death