BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 1915310 · Received November 2, 2010

    Report

    Report Number
    1518293-2010-00143
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 12, 2010
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY BIOMED INVESTIGATED AND BELIEVES THE STAFF WERE TRYING TO FLUORO WHILE IN THE TUBE WARM UP SCREEN. BIOMED HAS NOT BEEN ABLE TO REPRODUCE THE ERRORS, AND THE SYSTEM IS CURRENTLY FULLY OPERATIONAL AND IN SERVICE. TECH SUPPORT FOLLOW UP: BIOMED REPORTS THEY HAVE CLOSED THE WORK ORDER. THE SYSTEM IS FULLY FUNCTIONAL AND THE OPERATOR HAS NOT REPORTED THE PROBLEM AGAIN. BIOMED FEELS THE PROBLEM WAS DUE TO OPERATOR ERROR.

    Description of Event or Problem · 1

    ON 10/15: CUSTOMER REPORTS FEMALE HAVING AN UNK PROCEDURE WITH GENERAL ANESTHESIA WHEN FLUORO FAILED. PROCEDURE DELAYED APPROXIMATELY 30 MINUTES WHILE STAFF MOVED PT TO ANOTHER ROOM. PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. CUSTOMER REPORTS THE PT IS FINE. NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUT EXT DR FINAL ASSY-REVERSE UROLOGY SUITE KQS LIEBEL-FLARSHEIM CO. HUT EXT DR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK