BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEPAK 11 DIAGNOSTIC CARDIAC MONITOR

    MDR report key: 117855 · Received September 3, 1997

    Report

    Report Number
    3015876-1997-00438
    Event Type
    Death
    Date Received
    September 3, 1997
    Date of Event
    July 31, 1997
    Report Date
    September 3, 1997
    Manufacturer
    PHYSIO-CONTROL CORP.
    Product Code
    LDD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EMS PERSONNEL RESPONDED TO A SEMI-CONSCIOUS PT IN AN APPARENT HEROIN OVERDOSE. THE PT WAS BEING MONITORED EN ROUTE TO THE HOSPITAL AND ALLEGEDLY THE MONITOR INDICATED A LOW BATTERY CONDITION. THE OPERATOR REPLACED THE BATTERY AND OBSERVED THE PT TO BE IN VENTRICULAR FIBRILLATION. REPORTEDLY THE LOW BATTERY ALARM WAS ACTIVATED A SECOND TIME AND THE MONITOR LOST POWER. A THIRD BATTERY WAS INSTALLED AND THE PT WAS OBSERVED TO BE ASYSTOLIC. IT WAS REPORTED BY THE OPERATOR THAT DEFIBRILLATION THERAPY WAS ADMINISTERED DUE TO EQUIPMENT FAILURE. THE PT WAS NOT RESUSCITATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 11 DIAGNOSTIC CARDIAC MONITOR EXTERNAL CARDIAC MONITOR LDD PHYSIO-CONTROL CORP. 11 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR LIFEPAK 11 DEFIBRILLATOR/PACEMAKER