BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 2141320 · Received June 1, 2011

    Report

    Report Number
    3015876-2011-00432
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    April 6, 2011
    Report Date
    May 5, 2011
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K973486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL FURTHER EVALUATED THE REMOVED SYSTEM AND MEMORY PCB ASSEMBLIES AND DETERMINED THE CAUSE OF THE REPORTED FAILURE TO BE DUE TO A CONNECTION ISSUE BETWEEN THE TWO PCB ASSEMBLIES.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE DEVICE AUDIO WAS EXTREMELY LOW. THERE WAS NO PT USE ASSOCIATED WITH THE REPORTED FAILURE. PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE SYSTEM CONTROLLER PCB AND MEMORY PCB ASSEMBLIES AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE. PHYSIO-CONTROL FURTHER EVALUATED THE REMOVED SYSTEM CONTROLLER PCB AND MEMORY PCB ASSEMBLIES AT THE FAILURE ANALYSIS CENTER AND OBSERVED AN INTERMITTENT LOCK-UP AND RESET FAILURE.

    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