BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORCE 2 GENERATOR

    MDR report key: 529453 · Received June 9, 2004

    Report

    Report Number
    1717344-2004-00039
    Event Type
    Injury
    Date Received
    June 9, 2004
    Date of Event
    May 10, 2004
    Report Date
    May 14, 2004
    Manufacturer
    VALLEYLAB
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: C-SECTION. REPORTEDLY, THE REM ALARM WOULD NOT RESET AFTER THE ALARM CONDITION OCCURRED. WHILE TRYING TO REACTIVATE THE MACHINE THE PT LOST 1.3 LITRES OF BLOOD. A SECOND MACHINE WAS BROUGHT IN WHICH WORKED AND COMPLETED THE PROCEDURE. NO INFO HAS BEEN PROVIDED ABOUT THE OTHER DEVICES BEING USED IN THIS PROCEDURE SUCH AS THE PENCIL OR REM PAD. NO OTHER FURTHER INFO IS AVAILABLE ABOUT PT CHARACTERISTICS OR DETAILS OF THE PROCEDURE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORCE 2 GENERATOR ELECTRO-SURGICAL POWER UNIT GEI VALLEYLAB * *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other