BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD1200 DEFIBRILLATOR/PACEMAKER

    MDR report key: 1052170 · Received May 20, 2008

    Report

    Report Number
    1220908-2008-01158
    Event Type
    Malfunction
    Date Received
    May 20, 2008
    Date of Event
    March 2, 2008
    Report Date
    April 18, 2008
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL MEDICAL BECAME AWARE OF THIS REPORTED EVENT AFTER RECEIVING A MAUDE EVENT REPORT FROM THE FDA. DURING A FOLLOW UP WITH THE CUSTOMER, THEY INDICATED THAT WILL NOT BE RETURNING THE DEVICE TO ZOLL MEDICAL FOR EVALUATION.

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT, THE DEVICE WOULD NOT DISCHARGE VIA ELECTRODE PADS. THE USER THEN SWITCHED TO PADDLES AND DURING DISCHARGE A LARGE SPARK WAS OBSERVED. THE USER DELIVERED A SECOND SHOCK SUCCESSFULLY VIA PADDLES AND A SPARK WAS OBSERVED. 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
    1 PD1200 DEFIBRILLATOR/PACEMAKER DEFIBRILALTOR LDD ZOLL MEDICAL CORPORATION PD1200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1