BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 1082802 · Received July 24, 2008

    Report

    Report Number
    1518293-2008-00237
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    June 26, 2008
    Report Date
    June 26, 2008
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SVC ENGINEER FOUND A LOOSE CONNECTION ON THE IMAGE INTENSIFIER AND RECONNECTED AND REPLACED THE 24 VOLT POWER SUPPLY. HE VERIFIED THE OPERATION OF THE UROLOGY EQUIPMENT USING MAINTENANCE SECTION OF SVC MANUAL, AND RETURNED UNIT TO SVC.

    Description of Event or Problem · 1

    BIO MEDICAL ENGINEER REPORTED THAT A MALE PT WAS UNDERGOING A CYSTOGRAM PROCEDURE WHEN THE FLUORO STOPPED WORKING. HE REPORTED THAT THE PHYSICIAN WAS ABLE TO CONTINUE ON AND COMPLETED THE PROCEDURE WITHOUT ANY COMPLICATIONS BY USING SPOT FILMS AND LAST IMAGE HELD PICTURE ON THE MONITOR.

    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