BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK EXPRESS(R) DEFIBRILLATOR

    MDR report key: 2883807 · Received December 21, 2012

    Report

    Report Number
    3015876-2012-00941
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    October 8, 2012
    Report Date
    December 4, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS DUE TO AN OPEN TRACE ON THE ANALOG PCB ASSEMBLY BETWEEN INTEGRATED CIRCUIT, DESIGNATOR U1 AND RESISTOR, DESIGNATOR R81. THE CUSTOMER RECEIVED A REPLACEMENT DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY REPORTED THAT THEIR DEVICE WAS SHOWING ITS SERVICE WRENCH ICON. AFTER AN EVALUATION BY PHYSIO-CONTROL, IT WAS OBSERVED THAT THE DEVICE WOULD ONLY DELIVER A MONOPHASIC DEFIBRILLATION WAVEFORM WHICH AFFECTED THE AMOUNT OF ENERGY DELIVERED AND IT WOULD ALSO HAVE A VOICE PROMPT STATING "ENERGY NOT DELIVERED". WITH THIS MESSAGE COMING FROM THE DEVICE, THE END USER IS LIKELY TO THINK THE DEVICE DIDN'T DELIVER THE DEFIBRILLATION ENERGY CORRECTLY AND COULD ABANDON USE OF THE DEVICE. THIS WOULD THEN POTENTIALLY CAUSE A DELAY IN THERAPY TO A PATIENT. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1