BEUDAMED
    FDA Adverse Event Other Summary report: N

    FORCE EZ-C

    MDR report key: 687595 · Received February 20, 2006

    Report

    Report Number
    687595
    Event Type
    Other
    Date Received
    February 20, 2006
    Date of Event
    November 11, 2005
    Report Date
    February 20, 2006
    Manufacturer
    VALLEYLAB
    Product Code
    GEI
    Report Source
    User Facility report
    Reporter Location
    NC, US

    Narratives

    Description of Event or Problem · 1

    CLINICAL ENGINEERING CAME IN EARLY IN AM TO DO PMS FOR ENDOSCOPY. WHEN PHYSICIAN WENT TO USE NEW ESU, THE OUTPUT SETTING WAS ON HIGH. WHEN TESTING OUTPUT, CHECKING FROM LOW TO HIGH, THE TECH SHUT THE UNIT OFF IN HIGH ASSUMING THAT IT WOULD RETURN TO LOWEST SETTING BY DEFAULT LIKE ALL OF OUR OLDER UNITS. WHEN INSERVICED BY THE VENDOR, NO ONE WAS TOLD ABOUT THE DEFAULT SETTINGS. PATIENT WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORCE EZ-C ELECTROSURGICAL UNIT GEI VALLEYLAB FORCE EZ-C *

    Patients

    Seq Age Sex Outcome Treatment
    1 *