BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 2061398 · Received March 18, 2011

    Report

    Report Number
    3015876-2011-00256
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 17, 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
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL REPLACED THE SYSTEM/MEMORY PCB 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 SYSTEM/MEMORY PCB ASSEMBLY AT THE FAILURE ANALYSIS CENTER AND DETERMINED THE CAUSE OF THE FAILURE TO BE AN OPEN FILTER, DESIGNATOR FL137.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE DEVICE HAD A BLANK DISPLAY. UPON EVAL BY PHYSIO-CONTROL, IT WAS OBSERVED THAT THE DEVICE FROZE WITH A LOCK UP FAILURE. THE DEVICE WAS INOPERABLE WHILE IN THIS STATE. THERE WAS NO 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