BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 3905843 · Received July 1, 2014

    Report

    Report Number
    3015876-2014-00747
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K103567
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL FURTHER EVALUATED THE REMOVED MAIN KEYPAD ASSEMBLY AND DETERMINED THAT THE RIGHT SIDE OF THE CHARGE KEY WAS DAMAGED AND NEARLY SHORTED. THIS WOULD CAUSE THE CHARGE KEY TO INTERMITTENTLY ACTIVATE WHEN THE ENERGY UP/DOWN OR SHOCK BUTTONS WERE PUSHED, WHICH PROHIBITED THE FUNCTION OF THESE KEYS.

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO OBSERVED THAT THE SHOCK KEY WAS REGISTERING AS BEING PRESSED ALL THE TIME, CAUSING THE CONNECT ELECTRODES MESSAGE. PHYSIO THEN REPLACED THE MAIN KEYPAD ASSEMBLY AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR DEVICE WAS INTERMITTENTLY DISPLAYING A "CONNECT ELECTRODES" MESSAGE. WHEN THE DEVICE IS DISPLAYING THIS MESSAGE, THE DEVICE COULD POTENTIALLY NOT HAVE THE ABILITY TO DELIVER DEFIBRILLATION THERAPY TO A PATIENT. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE. UPON EVALUATION OF THE DEVICE, IT WAS OBSERVED THAT THE SHOCK BUTTON WAS ALWAYS REGISTERING AS BEING PRESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382742 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 15

    Patients

    Seq Age Sex Outcome Treatment
    1