BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR

    MDR report key: 3150788 · Received June 6, 2013

    Report

    Report Number
    3015876-2013-00477
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 9, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    LDD
    PMA / PMN Number
    K063119
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND WAS UNABLE TO VERIFY THE REPORTED FAILURE. AS A PRECAUTION, PHYSIO REPLACED THE MAIN KEYPAD AND THE USER INTERFACE / SYSTEM CONTROLLER PCB ASSEMBLIES. PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING AND THE DEVICE WILL BE RETURNED TO THE CUSTOMER FOR USE. THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CHARGE BUTTON ON THE CUSTOMER'S DEVICE WAS INTERMITTENTLY FUNCTIONAL. THE REPORTED FAILURE WAS NOTICED DURING A PATIENT EVENT WHERE THE PATIENT WAS BEING TREATED WITH THE SYNCHRONIZED CARDIOVERSION THERAPY AND THE DEVICE WOULDN'T CHARGE THE DEFIBRILLATION ENERGY WHEN THE CHARGE BUTTON WAS PRESSED. THE CUSTOMER ADVISED THAT THE PATIENT WAS TREATED WITH A BACK-UP DEVICE WITH A MINIMAL DELAY. THERE WAS NO REPORT OF ANY ADVERSE EFFECT TO THE PATIENT FROM A RESULT OF THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250905 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR DC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES) LDD PHYSIO-CONTROL, INC 20

    Patients

    Seq Age Sex Outcome Treatment
    1