BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 3123156 · Received May 21, 2013

    Report

    Report Number
    3015876-2013-00419
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 24, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K102972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    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 REPAIRED AND RETURNED TO THE CUSTOMER FOR USE.FURTHER EVALUATION OF THE REMOVED SYSTEM/MEMORY PCB ASSEMBLY AT THE FAILURE ANALYSIS CENTER WAS UNABLE TO DETERMINE FURTHER CAUSE FOR THE INTERMITTENT FREEZING PROBLEM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE WAS NOT RETAINING THE TIME AND DATE SETTINGS AND THE TIME WAS NOT ADVANCING. PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED PROBLEM. FURTHERMORE, IT WAS OBSERVED THAT THE DEVICE INTERMITTENTLY FROZE DURING THE POWER ON SELF-TEST, A LOCK UP FAILURE. THERE WAS NO PATIENT USE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225086 LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1