BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 932048 · Received October 22, 2007

    Report

    Report Number
    3015876-2007-00426
    Event Type
    Death
    Date Received
    October 22, 2007
    Date of Event
    September 22, 2007
    Report Date
    September 25, 2007
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL, INC. EVALUATED THE DEVICE BUT WAS UNABLE TO DUPLICATE THE REPORTED CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED TO DEFIBRILLATE THE PATIENT, A 67 PT WITH A HISTORY OF HYPERTENSION AND DIABETES, BUT THE DEVICE GAVE A CONNECT ELECTRODES ALARM. A SECOND DEVICE (AN AED) AND A SECOND SET OF ELECTRODES WERE USED, WAS USED TO ATTEMPT DEFIBRILLATION. THE PATIENT EXPIRED. THE CUSTOMER STATED THAT THEY DID NOT BELIEVE THE PATIENTS DEATH WAS ATTRIBUTABLE TO THE DEVICE AS A BACKUP DEVICE WAS USED WITHOUT SIGNIFICANT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES MKJ PHYSIO-CONTROL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death