BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL PD-1200

    MDR report key: 16026 · Received July 21, 1994

    Report

    Report Number
    16026
    Event Type
    Malfunction
    Date Received
    July 21, 1994
    Date of Event
    April 10, 1994
    Report Date
    April 11, 1994
    Manufacturer
    ZMI CORPORATION
    Product Code
    DRK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT BROUGHT IN BY AMBULANCE IN FULL CARDIOPULMONARY ARREST WITH CPR IN PROGRESS. QUICK-LOOK PADDLES APPLIED AND PATIENT DEFIBRILLATED AT 200 JOULES. AFTER INITIAL DEFIBRILLATION, THEY COULD NOT OBTAIN THE PATIENT'S RHYTHM WITH THE PADDLES. TIME HAD TO BE TAKEN TO ATTACH LEADS BEFORE THEY COULD GIVE THEIR SECOND DEFIBRILLATION. WE FOLLOW ACLS PROTOCOLS WHICH CALLS FOR 3 RAPID DEFIBRILLATIONS IN SUCCESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZOLL PD-1200 MONITOR/DEFIBRILLATOR/PACEMAKER DRK ZMI CORPORATION PD 1200

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other