BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 2080026 · Received April 6, 2011

    Report

    Report Number
    3015876-2011-00304
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 9, 2011
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO 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. PHYSIO FURTHER EVALUATED THE REMOVED MAIN KEYPAD ASSEMBLY AND DETERMINED THE CAUSE OF THE FAILURE TO BE OXIDATION OF THE FINGER CONTACT FOR THE LEFT BUBBLE OF THE ON SWITCH.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE DEVICE HAD AN ILLUMINATED SERVICE INDICATOR; HOWEVER, UPON EVAL BY PHYSIO-CONTROL, IT WAS OBSERVED THAT THE DEVICE WOULD ONLY POWER ON INTERMITTENTLY WHEN THE ON BUTTON WAS PRESSED. THERE WAS NO REPORT OF PT 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