BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK II DEFIBRILLATOR/PACEMAKER

    MDR report key: 199070 · Received November 20, 1998

    Report

    Report Number
    3015876-1998-00569
    Event Type
    Malfunction
    Date Received
    November 20, 1998
    Date of Event
    October 21, 1998
    Report Date
    November 20, 1998
    Manufacturer
    PHYSIO-CONTROL CORP.
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FIRE DEPT PERSONNEL WERE TREATING A PT WHO REQUIRED DEFIBRILLATION. A TOTAL OF SIX DEFIBRILLATION ATTEMPTS WERE MADE. THE REPORTER ALLEGED THAT THE LAST THREE DEFIBRILLATION ATTEMPTS WERE NOT DELIVERED TO THE PT. REPORTEDLY, THE DEVICE DISPLAYED ENERGY NOT DELIVERED ON THE MONITOR SCREEN. THIS WAS ACCOMPANIED HY A LACK OF MUSCULAR SKELETAL RESPONSE FROM THE PT WHEN THE LAST THREE DEFIBRILLATOR ATTEMPTS WERE MADE. THE PT WAS TRANSPORTED TO THE EMERGENCY DEPT. THE REPORTER STATED THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE PT'S OUTCOME. THE STATEMENT WAS BASED ON THE PARAMEDIC'S ASSESSMENT OF THE PT'S LACK OF VIABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK II DEFIBRILLATOR/PACEMAKER EXTERNAL DC DEFIBRILLATOR/TRANSCUTANEOUS PACER LDD PHYSIO-CONTROL CORP. 11 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR