BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1964693 · Received December 23, 2010

    Report

    Report Number
    3015876-2010-01420
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Date of Event
    November 30, 2010
    Report Date
    November 30, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A THIRD PARTY BIOMED REPORTED THAT THE DEVICE WOULD INTERMITTENTLY FAIL TO CHARGE DEFIBRILLATION ENERGY AND ILLUMINATED THE SERVICE ICON. THERE WAS NO KNOWN 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