BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUIK-COMBO PACING/DEFIBRILLATION/ECG CABLE

    MDR report key: 112548 · Received August 6, 1997

    Report

    Report Number
    3015876-1997-00397
    Event Type
    Malfunction
    Date Received
    August 6, 1997
    Report Date
    August 6, 1997
    Manufacturer
    PHYSIO-CONTROL CORPORATION
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT DURING ROUTINE DAILY TESTING IT WAS OBSERVED THAT THE DEFIBRILLATOR OUTPUT WS LOW (180-183 JOULES) WHEN 200 JOULES WAS SELECTED. AN ADDITIONAL SHOCK AT 360 JOULES RESULTED IN ARCING AND CABLE DAMAGE AT A MIDWAY POINT OF THE CABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUIK-COMBO PACING/DEFIBRILLATION/ECG CABLE PACING/DEFIBRILLATION/ECG CABLE LDD PHYSIO-CONTROL CORPORATION 9 5096

    Patients

    Seq Age Sex Outcome Treatment
    1 * LIFEPAK 9 DEFIBRILLATOR/MONITOR.