BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 3063540 · Received April 17, 2013

    Report

    Report Number
    3015876-2013-00303
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 21, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K102972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL DETERMINED THE CAUSE FOR THE MALFUNCTION TO BE THE MAIN CONTROL KEYPAD ASSEMBLY. PHYSIO REPLACED THE KEYPAD ASSEMBLY AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER FOR USE. ADDITIONAL EVALUATION OF THE REMOVED KEYPAD ASSEMBLY AT THE FAILURE ANALYSIS CENTER WAS UNABLE TO DETERMINE FURTHER CAUSE FOR THE FAILURE.

    Description of Event or Problem · 1

    DURING A SCHEDULED DEVICE EVALUATION, PHYSIO-CONTROL FOUND THAT THE DEVICE INTERMITTENTLY FAILED TO TURN ON WHEN THE POWER BUTTON WAS PRESSED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165316 LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1