BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCETRIAD ENERGY PLATFORM

    MDR report key: 4728813 · Received April 24, 2015

    Report

    Report Number
    1717344-2015-00302
    Event Type
    Malfunction
    Date Received
    April 24, 2015
    Date of Event
    January 13, 2015
    Report Date
    January 15, 2015
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE UNIT WAS SERVICED AT THE CUSTOMER'S SITE AND INVESTIGATIONS FOUND THAT THE REM DID NOT ALARM WHEN THE REM IMPEDANCE WAS REDUCED TO ZERO OHMS. THE INVESTIGATION ISOLATED THE FAILURE TO THE GENERATOR NEEDING TO BE CALIBRATED, BUT A ROOT CAUSE WAS NOT IDENTIFIED. THE GENERATOR WAS CALIBRATED AND THE REM IMPEDANCE WAS REDUCE TO FIVE OHMS AND IT ALARMED.

    Description of Event or Problem · 1

    THE CUSTOMER REQUESTED AN ONSITE PREVENTATIVE MAINTENANCE SERVICE. INITIAL EVALUATION FOUND THAT THE REM DID NOT ALARM WHEN THE REM IMPEDANCE WAS REDUCED TO ZERO OHMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274179 FORCETRIAD ENERGY PLATFORM ELECTROSURGICAL GENERATOR GEI COVIDIEN LP FORCETRIAD

    Patients

    Seq Age Sex Outcome Treatment
    1