BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 2063252 · Received March 22, 2011

    Report

    Report Number
    1518293-2011-00053
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 1, 2011
    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

    FIELD SERVICE ENGINEER CONFIRMED THE X-RAY GENERATOR CONSOLE TURNS ON BUT HAD NO DISPLAY. HOWEVER, THE SYSTEM WAS ABLE TO TAKE EXPOSURES, I.E. COULD FLUORO. NORMALLY, IF THE SEDECAL CONSOLE DISPLAY DOES NOT WORK, IT DOES NOT CAUSE FLUORO TO FAIL. FSE REPLACED THE INTEGRATED GENERATOR CONSOLE AND COMPLETED CONFIGURATION PER SERVICE MANUAL AND COMPLETED AN OPERATIONAL CHECKOUT AND VERIFICATION OF SYSTEM PER SERVICE CHECKLIST. SYSTEM FUNCTIONS NORMAL AND WAS RETURNED TO FULL SERVICE BY THE CUSTOMER.

    Description of Event or Problem · 1

    ON (B)(6): STAFF REPORTS MALE PATIENT HAVING A RETROGRADE CYSTOGRAM PROCEDURE WHEN THE FLUORO FAILED. PHYSICIAN HAD TO ABORT THE RETROGRADE CYSTOGRAM. 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