BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 7

    MDR report key: 45504 · Received September 20, 1996

    Report

    Report Number
    3015876-1996-00023
    Event Type
    Malfunction
    Date Received
    September 20, 1996
    Date of Event
    August 5, 1996
    Report Date
    August 16, 1996
    Manufacturer
    PHYSIO-CONTROL
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DEFIBRILLATOR WAS USED DURING A CARDIAC ARREST AND DID NOT DISCHARGE UPON DEPRESSING THE CHARGE RELEASE BUTTONS IN THE PADDLES. THE MACHINE WAS DISCONNECTED IMMEDIATELY AND ANOTHER ONE REPLACED IT. IT IS UNKNOWN WHAT CAUSED THE MALFUNCTION TO OCCUR. THE PT WAS SUCCESSFULLY DEFIBRILATED AND TRANSFERRED TO THE CORONARY CRITICAL CARE UNIT AND EXPIRED FOUR YRS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 7 DEFIBRILLATOR HSH PHYSIO-CONTROL LP7 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Life Threatening