BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1964663 · Received December 23, 2010

    Report

    Report Number
    3015876-2010-01427
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 22, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL REPLACED THE BIPHASIC MODULE PCB ASSEMBLY AND POWER PCB ASSEMBLY TO OBSERVE PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. PHYSIO DETERMINED THE CAUSE OF THE FAILURE TO BE FAILURE OF AN IC CHIP, DESIGNATOR U12, ON THE BIPHASIC MODULE PCB ASSEMBLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE ILLUMINATED THE SERVICE INDICATION AND LOGGED EVENT CODES IN THE MEMORY. THERE WAS NO PT USE ASSOCIATED WITH THE EVENT. PHYSIO-CONTROL'S INVESTIGATION FOUND THAT THE DEVICE WAS NOT ABLE TO PROVIDE DEFIBRILLATION THERAPY.

    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