BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1964689 · Received December 23, 2010

    Report

    Report Number
    3015876-2010-01421
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 3, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL REPLACED THE THERAPY PCB ASSEMBLY AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE. PHYSIO FURTHER EVALUATED THE REMOVED THERAPY PCB ASSEMBLY AT THE FAILURE ANALYSIS CENTER AND WAS UNABLE TO VERIFY OR DUPLICATE THE FAILURE. FURTHER EXTENSIVE TESTING WAS UNABLE TO DETERMINE FURTHER CAUSE OF THE PROBLEM.

    Description of Event or Problem · 1

    PHYSIO-CONTROL INSPECTED THE DEVICE AND FOUND IT WITH AN ILLUMINATED SERVICE LIGHT AND FAILING TO DELIVER DEFIBRILLATION THERAPY UPON THE FIRST TIME USE, AN OUT OF BOX FAILURE. THE DEVICE WAS STORED UNOPENED IN A BOX FOR A YEAR. 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