BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 2081446 · Received April 12, 2011

    Report

    Report Number
    3015876-2011-00318
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 14, 2011
    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 EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE USER INTERFACE PCB ASSEMBLY AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE RETURNED TO THE CUSTOMER FOR USE. PHYSIO FURTHER EVALUATED THE REMOVED USER INTERFACE PCB ASSEMBLY AND DETERMINED THE CAUSE OF THE REPORTED FAILURE TO BE THE SOLDER WAS NOT ADHERED TO THE PADS OF PINS 4 AND 5 OF AN INTEGRATED CIRCUIT CHIP, DESIGNATOR U4. THIS CAUSED INTERMITTENT OPERATION OF THE "ENERGY SELECT" AND "CHARGE" BUTTONS.

    Description of Event or Problem · 1

    IT WAS OBSERVED THAT THEY WOULD NOT DELIVER DEFIBRILLATION THERAPY MANUALLY USING THE "CHARGE" AND "ENERGY SELECT" BUTTONS. THE DEVICE WOULD, HOWEVER, STILL DELIVER DEFIBRILLATION THERAPY USING THE AED MODE. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    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