BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 2182233 · Received July 12, 2011

    Report

    Report Number
    1518293-2011-00119
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 15, 2011
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER TROUBLESHOT SYSTEM AND VERIFIED THE X-RAY TUBE WAS MAKING X-RAYS AND THE IMAGE INTENSIFIER (I.I.) WAS PRODUCTING AN IMAGE. FSE FOUND THE CAMERA CABLE WAS NOT CONNECTED TO THE CORRECT POSITION. SOMEONE HAD CONNECTED THE CAMERA CABLE DIRECTLY TO THE CABLE IN THE TABLE THAT CONNECTS WITH THE GOLD ONE INSTEAD OF THE IMAGE INTENSIFIER. THIS CONFIGURATION PRODUCED NO IMAGE. FSE CORRECTED THIS BY CONNECTING THE CAMERA CABLE CONNECTION TO THE I.I. AND THE IMAGE WAS RESTORED. FSE CALIBRATED THE CAMERA AND SAVED CHANGES MADE DURING CONFIGURATION. FSE TESTED ALL FLUOROSCOPY MODES AND SPOT FILM AND UNIT PASSED ALL TESTS. ALL CALIBRATIONS AND DISASSEMBLY/REASSEMBLY COMPLETED PER SERVICE MANUALS AND THE UNIT WAS RETURNED TO FULL SERVICE BY THE CUSTOMER.

    Description of Event or Problem · 1

    ON (B)(6): CUSTOMER REPORTS A PATIENT UNDERGOING UNDETERMINED UROLOGY PROCEDURE WHEN FLUORO FAILED. THE PATIENT WAS MOVED TO ANOTHER ROOM WHERE THE PHYSICIAN COMPLETED THE PROCEDURE WITHOUT FURTHER INCIDENT. PATIENT IS FINE. CUSTOMER WOULD NOT PROVIDE ANY PATIENT OR PROCEDURAL INFORMATION FROM THAT POINT. 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