BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VALLEYLAB

    MDR report key: 6847522 · Received September 6, 2017

    Report

    Report Number
    3006451981-2017-05576
    Event Type
    Malfunction
    Date Received
    September 6, 2017
    Report Date
    August 17, 2017
    Manufacturer
    COVIDIEN MEDICAL PRODUCTS
    Product Code
    GEI
    UDI-DI
    10884524002637
    PMA / PMN Number
    K944602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE USED FORCEFX8CAS WAS RECEIVED, AND EVALUATION OF THE RETURNED DEVICE CONFIRMED AN REM ISSUE. TESTING OF THE DEVICE FOUND THE UPPER REM RANGE IS EXCEEDED BEFORE THE DEVICE WILL ALARM. THE INVESTIGATION ISOLATED THE FAILURE TO THE REM ADAPTER ASSEMBLY, BUT A ROOT CAUSE WAS NOT IDENTIFIED. THE PROBABLE ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE INFORMATION PROVIDED. THE REM ADAPTER ASSEMBLY WAS REPLACED TO ADDRESS THE CONDITION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ERROR OCCURRED WHEN A NEUTRAL ELECTRODE WAS CONNECTED. THERE WAS NO PATIENT INVOLVEMENT. EXAMINATION OF THE RETURNED SAMPLE BY MEDTRONIC FOUND THE UPPER REM RANGE OF THE DEVICE WAS OUTSIDE OF SPECIFICATIONS AND THE RED LED SIGNAL WAS DELAYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624135 VALLEYLAB ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MEDICAL PRODUCTS FORCEFX-8CAS 10884524002637

    Patients

    Seq Age Sex Outcome Treatment
    1