BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1932799 · Received December 1, 2010

    Report

    Report Number
    3015876-2010-01310
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 3, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL IS IN THE PROCESS OF REPAIRING THE DEVICE AND CONTINUES TO INVESTIGATE THE REPORTED/OBSERVED FAILURE. PHYSIO-CONTROL WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE DEVICE FAILED THE USER TEST. PHYSIO-CONTROL EVALUATED THE DEVICE AND FOUND THAT IT WOULD NOT CHARGE TO THE SELECTED ENERGY AND HAD LOGGED AN EVENT CODE IN THE MEMORY. THE DEVICE WAS UNABLE TO DELIVER DEFIBRILLATION THERAPY IN THE OBSERVED CONDITION. THERE WAS NO PATIENT USE ASSOCIATED WITH THE EVENT.

    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 NA