BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 2093524 · Received April 5, 2011

    Report

    Report Number
    1518293-2011-00055
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 9, 2011
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER TROUBLESHOT AND FOUND THE ALIGNMENT ISSUES WAS DUE TO THE IMAGE SYSTEM TRANSDUCER BOARD BEING DAMAGED WHEN FLUID GOT INTO THE TUB. QA DISCUSSED ISSUES WITH FSE WHO SAID THAT FLUID FROM PROCEDURES GOT UNDER TABLE WHEN PATIENT TILTED HEAD DOWN AND DRAIN BAG ASSEMBLY WAS CLOSED OR COLLAPSED INADVERTENTLY BY THE PHYSICIAN. FSE REPLACED TRANSDUCER BOARD AND RESEALED TUB AND VERIFIED PROPER OPERATION PER SERVICE CHECKLIST. SYSTEM RETURNED TO FULL SERVICE BY THE CUSTOMER.

    Description of Event or Problem · 1

    ON (B)(6): CUSTOMER REPORTS PATIENT UNDERGOING A UROLOGY PROCEDURE WHEN FLUORO FAILED. PHYSICIAN WAS ABLE TO FINISH PROCEDURE BY USE OF ENDOSCOPY CAMERA. CUSTOMER PROVIDED NO PATIENT OR PROCEDURAL INFORMATION OTHER THAN TO SAY PROCEDURE COMPLETED AND PATIENT 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