BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRO SURGICAL UNIT

    MDR report key: 1151569 · Received September 3, 2008

    Report

    Report Number
    1151569
    Event Type
    Malfunction
    Date Received
    September 3, 2008
    Date of Event
    August 25, 2008
    Report Date
    September 2, 2008
    Manufacturer
    VALLEY LAB INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EQUIPMENT WOULD NOT FUNCTION WHEN NEEDED IN SURGICAL SUITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTRO SURGICAL UNIT NONE GEI VALLEY LAB INC. FORCE FX NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other