BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 1218585 · Received October 31, 2008

    Report

    Report Number
    1518293-2008-00349
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    October 23, 2008
    Report Date
    October 23, 2008
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIEBREL FLARSHIEM MANUFACTURING REPORT: FIELD SERVICE ENGINEER INVESTIGATED AND FOUND THE PROBLEM WAS A LOOSE CABLE IN THE GIM BOX. FSE NOTED THE COMPUTER TOWER AND GIM BOX HAD BEEN MOVED TO A SHELF FROM THE ORIGINAL POSITION. FSE FOUND A CABLE IN THE GIM BOX HAD WORKED LOOSE. FSE RE-SECURED THIS AND ALL CABLES IN THE GIM BOX WAS ABLE TO FLUORO AND DO PHOTO SPOT EXPOSURE. FSE VERIFIED PROPER OPERATION ACCORDING TO HUT SERVICE MANUAL. SYSTEM RETURNED TO FULL SERVICE BY THE CUSTOMER.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT SYSTEM DID GO DOWN DURING A PATIENT PROCEDURE. CUSTOMER NOT WILLING TO DISCUSS PATIENT DETAILS, OTHER THAN TO SAY THERE WERE NO PROBLEMS WITH THE PATIENT PROCEDURE. PATIENT MOVED TO ANOTHER ROOM FOR THE PROCEDURE.

    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