BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 2022008 · Received March 10, 2011

    Report

    Report Number
    3015876-2011-00229
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    December 16, 2010
    Report Date
    February 9, 2011
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL REPLACED THE MAIN KEYBOARD ASSEMBLY AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE. PHYSIO-CONTROL EVALUATED THE REMOVED KEYPAD ASSEMBLY AT THE FAILURE ANALYSIS CENTER AND DETERMINED THE CAUSE OF THE FAILURE TO BE A WORN OFF CONDUCTIVE MATERIAL FROM THE ON/OFF SWITCH. THE MATERIAL CREATED A CONSTANT SHORT BETWEEN THE CONDUCTIVE FINGERS OF THE ASSEMBLY. THIS ISSUE COULD HAVE CAUSED THE DEVICE TO EXHIBIT POWER ON/OFF PROBLEMS WITH DEVICE MOVEMENT OR EXCESSIVE HEAT OR COLD.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE DEVICE WOULD POWER ON BY ITSELF AND WOULD NOT POWER OFF UNLESS THE BATTERIES WERE REMOVED. HOWEVER AFTER FURTHER EVALUATION OF THE REMOVED KEYPAD ASSEMBLY BY PHYSIO-CONTROL, IT WAS OBSERVED THAT THE DEVICE COULD HAVE ALSO FAILED TO POWER ON OR LOSE POWER. THERE WAS NO REPORT OF PATIENT 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