BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIFE PAK-7

    MDR report key: 32721 · Received May 6, 1996

    Report

    Report Number
    MW1009030
    Event Type
    Other
    Date Received
    May 6, 1996
    Date of Event
    March 25, 1996
    Report Date
    May 2, 1996
    Manufacturer
    PHYSIO CONTROL
    Product Code
    LDD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE MALFUNCTION OF THE DEFIBRILLATOR OCCURRED ON 3/25/96 DURING A CODE. THE PT RECEIVED A SHOCK OF 200 JOULES WITH ANOTHER MFR'S DEFIBRILLATOR FIRST AND THERE WAS NO RESPONSE TO THIS SHOCK ON THE AGONAL RHYTHM. ALTHOUGH THE HOUSESTAFF AND THE PHYSICIANS SAW SPARKS, THE BODY DID NOT JUMP EXTENSIVELY AS THEY WERE USED TO AND THEREFORE AFTER TWO SHOCKS WITH ONE MACHINE (OTHER MFR'S) THEY ELECTED TO GO WITH THIS MACHINE. THE CODE WAS NOT SUCCESSFUL AND THE PT EXPIRED, BUT THE DEATH APPEARS TO BE UNRELATED TO THE POSSIBLE MALFUNCTION OF THE DEFIBRILLATORS. BOTH DEFIBRILLATORS WERE REMOVED FROM THE FLOOR AND RETURNED TO THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFE PAK-7 DEFIBRILLATOR LDD PHYSIO CONTROL 801380-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other