BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR

    MDR report key: 3120920 · Received May 20, 2013

    Report

    Report Number
    3015876-2013-00410
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 23, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K073089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER EVALUATION OF THE REMOVED THERAPY PCB ASSEMBLY DETERMINED THE CAUSE FOR THE INTERMITTENT MALFUNCTION TO BE FAILURE OF AN IC CHIP, DESIGNATOR U7.

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED INTERMITTENT FAILURE. PHYSIO REPLACED THE THERAPY PCB ASSEMBLY AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE INTERMITTENTLY CONTINUOUSLY REBOOTS AND FAILS TO COMPLETE THE NORMAL START UP PROCESS. THE DEVICE WOULD NOT BE AVAILABLE FOR USE IN THE REPORTED CONDITION. THERE WAS NO PATIENT USE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221836 LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 20E

    Patients

    Seq Age Sex Outcome Treatment
    1