BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1170329 · Received September 12, 2008

    Report

    Report Number
    3015876-2008-01110
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Date of Event
    August 15, 2007
    Report Date
    August 15, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE AUTO-ANALYZE FEATURE IS TURNING ON WHEN THE DEVICE IS CONNECTED TO PATIENTS. THE CUSTOMER HAS TURNED THE AUTO-ANALYZE FEATURE TO "OFF" BUT THE UNIT CONTINUES TO ANALYZE. THERE WERE NO REPORTS OF ADVERSE EFFECTS TO ANY OF THE PATIENTS.

    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 UNK