BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 1000 DEFIBRILLATOR

    MDR report key: 3924669 · Received July 10, 2014

    Report

    Report Number
    3015876-2014-00789
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    April 7, 2014
    Report Date
    June 13, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K042404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A THIRD-PARTY SERVICE AGENT EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED FAILURE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO-CONTROL DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS DUE TO A REGULATOR, DESIGNATOR U31 ON THE ANALOG PCB ASSEMBLY THAT DID NOT HAVE A -5V OUTPUT. THIS CAUSED THE ECG TO NOT RECOGNIZE ELECTRODES BEING CONNECTED TO THE DEVICE. A REPLACEMENT DEVICE WAS PROVIDED TO THE CUSTOMER UNDER WARRANTY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHYSIO-CONTROL THAT THE CUSTOMER'S DEVICE SHOWED A SERVICE WRENCH ICON IN THE READINESS DISPLAY. UPON EVALUATION OF THE DEVICE IT WAS OBSERVED THAT SEVERAL EVENT CODES HAD BEEN LOGGED INTO THE DEVICE'S MEMORY AND THAT THE DEVICE WOULD NOT RECOGNIZE ANY ELECTRODES BEING CONNECTED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402818 LIFEPAK(R) 1000 DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 1000

    Patients

    Seq Age Sex Outcome Treatment
    1