BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCETRIAD ENERGY PLATFORM

    MDR report key: 3945191 · Received May 5, 2014

    Report

    Report Number
    1717344-2014-00389
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Report Date
    April 30, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT UNIT HAS BEEN RECEIVED AND IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS REM ERROR. THE INITIAL EVALUATION FOUND THE REM MONITORING CIRCUIT IS VARYING AND CAN FALL OUT OF SPECIFICATION, COMPROMISING THE MONITORING OF THE PAD SITE. THIS INTERMITTENT OUT OF SPECIFICATION CONDITION MAY RESULT IN THE GENERATOR NOT DETECTING A PROBLEM AT THE PAD SITE. IT MAY ALSO RESULT IN THE SYS ALARMING WHEN NO ISSUE EXISTS AT THE PAD SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268317 FORCETRIAD ENERGY PLATFORM ELECTROSURGICAL GENERATOR GEI COVIDIEN LP

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK