BEUDAMED
    FDA Adverse Event Death Summary report: N

    PHYSIO CONTROL LIKEPAK 11

    MDR report key: 107502 · Received July 22, 1997

    Report

    Report Number
    107502
    Event Type
    Death
    Date Received
    July 22, 1997
    Date of Event
    July 5, 1997
    Report Date
    July 21, 1997
    Manufacturer
    PHYSIO CONTROL
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    ON 7/5/97, PRE-HOSPITAL PERSONNEL ATTEMPTED RESUSCITATION OF A PT IN FULL ARREST. THE MONITOR/DEFIBRILLATOR DISPLAYED SVT THROUGH COMBINATION MONITOR/DEFIB PADS AND USING THE "PADDLES" LEAD POSITION. THE PT WAS TREATED ACCORDINGLY WITH NUMEROUS COUNTERSHOCKS APPLIED. THE PT WAS PULSELESS BUT THE DISPLAYED RHYTHM CONTINUED. THE PT WAS THEN MONITORED USING 4-LEAD CABLE IN "LEAD II". ASYSTOLE WAS DISPLAYED. ANOTHER MONITOR/DEFIBRILLATOR WAS APPLIED AND ALSO DISPLAYED ASYSTOLE. THE PT WAS NOT RESUSCITATED. THE ORIGINAL MONITOR CONTINUED TO DISPLAY THE SVT WAVEFORM FOR A SHORT TIME AFTER BEING REMOVED FROM THE PT. THE SUSPECT MONITOR AS WELL AS THOSE IDENTICAL TO IT WERE REMOVED FROM SERVICE AND THE MFR SERVICE REP WAS NOTIFIED. ON 7/9/97 THE (MSR) DISCOVERED A BROKEN INTERCONNECT WIRE HARNESS AND BROKEN STAND-OFF POSTS (AN INTERNAL CASE COMPONENT). THE SIX REMAINING UNITS WERE LIKEWISE CHECKED; FOUR OF THEM WERE FOUND TO HAVE BROKEN STAND-OFF POSTS. THE MSR REPAIRED ONE OF THOSE UNITS AND SENT THE REMAINING THREE TO THE MFR FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHYSIO CONTROL LIKEPAK 11 MONITOR/DEFIBRILLATOR LDD PHYSIO CONTROL 11 (MONITOR/DEFIBRILLATOR) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death PACER| PHYSIO-CONTROL LIFEPAK 11 MONITOR/DEFIBRILLATOR/
    2