BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 5 DEFIBRILLATOR

    MDR report key: 117600 · Received August 29, 1997

    Report

    Report Number
    3015876-1997-00435
    Event Type
    Malfunction
    Date Received
    August 29, 1997
    Date of Event
    July 14, 1997
    Report Date
    August 29, 1997
    Manufacturer
    PHYSIO-CONTROL CORP.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PARAMEDICS ATTENDED TO A PERSON DESCRIBED AS IN FULL CARDIAC ARREST. THE PATIENT WAS DIAGNOSED IN VENTRICULAR FIBRILLATION. THE OPERATOR ADMINISTERED A COUNTERSHOCK TO THE PATIENT USING THE STANDARD EXTERNAL PADDLES. THE DEVICE ALLEGEDLY FAILED TO CHARGE WHEN A SECOND COUNTERSHOCK WAS ATTEMPTED. A BACKUP DEFBRILLATOR WAS IMMEDIATELY AVAILABLE AND USED. THE PATIENT WAS NOT RESUSCITATED. THE REPORTER INDICATED THAT THE ALLEGED MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEATH. THIS OPINION WAS BASED ON THE IMMEDIATE USE OF A BACKUP DEFIBRILLATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 5 DEFIBRILLATOR EXTERNAL DC DEFIBRILLATOR MKJ PHYSIO-CONTROL CORP. 5 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR