BEUDAMED
    FDA Adverse Event Death Summary report: N

    PHYSIO CONTROL LPIO

    MDR report key: 113783 · Received August 11, 1997

    Report

    Report Number
    113783
    Event Type
    Death
    Date Received
    August 11, 1997
    Date of Event
    July 27, 1997
    Report Date
    July 27, 1997
    Manufacturer
    PHYSIO CONTROL
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EIGHTY ONE Y.O. VICTIM OF CARDIAC ARREST. LPIO PACER ATTACHED TO PT FOR SYMPTOMATIC BRADY/ASYSTOLE. DEVICE WOULD NOT PACE & WOULD ALARM - LEADS OFF. F.D. PACER EMPLOYED. WHILE WORKING A CARDIAC ARREST IN ASYSTOLE THE CREW ATTEMPTED TO USE THE PACER AND WERE UNABLE TO PACE THE PT AS THE MONITOR SHOWED THERE TO BE A LEAD OFF, AFTER CONFIRMING THAT ALL LEADS WERE ATTACHED AND ATTEMPTING AGAIN TO PACE, THE MONITOR CONTINUED TO SHOW A LEAD UNATTACHED. THE LIFE PAK WAS TAKEN OUT OF SVC AND ALL OF THE PACING PADS WERE KEPT, AN EQUIPMENT FAILURE REPORT WAS COMPLETED, A COPY OF THE INCIDENT REPORT AND INVOICE WERE FORWARDED TO THE TRAINING DEPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHYSIO CONTROL LPIO MONITOR DEFIBRILLATOR LDD PHYSIO CONTROL 804200-14 8/96

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death| O| R