BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEFIBRILLATOR/MONITOR

    MDR report key: 25532 · Received August 8, 1995

    Report

    Report Number
    25532
    Event Type
    Death
    Date Received
    August 8, 1995
    Date of Event
    February 16, 1995
    Report Date
    March 14, 1995
    Manufacturer
    PHYSIO-CONTROL, CORP.
    Product Code
    KDD
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT ARRIVED IN ER IN CARDIAC ARREST. "HANDS-OFF" ELECTRODES APPLIED. PT WAS DEFIBRILLATED. ON 2ND ATTEMPT "ARCING" WAS NOTED. ELECTRODE CONNECTION WAS CHECKED AND PT WAS DEFIBRILLATED WITHOUT ARCING. THE DEFIBRILLATION WAS ATTEMPTED NINE TIMES, OF THESE NINE TIMES FIVE OF THE ATTEMPTS RESULTED IN ARCING ACROSS THE PT'S CHEST WITH RESULTANT SINGING OF THE CHEST HAIRS. ELECTRODE CONTACT WAS CHECKED BETWEEN ATTEMPTS, WITH NO INDICATION OF IMPROPER APPLICATION. PT EXPIRED. MFR WAS SENT DEFIBRILLATION CABLE ON 2/22/95. AWATING CONTACT FROM MFR ON CABLE ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEFIBRILLATOR/MONITOR DEFIBRILLATOR/MONITOR KDD PHYSIO-CONTROL, CORP. LIFEPAK 9 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death