BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 1081056 · Received July 21, 2008

    Report

    Report Number
    1518293-2008-00238
    Event Type
    Malfunction
    Date Received
    July 21, 2008
    Date of Event
    June 30, 2008
    Report Date
    June 30, 2008
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIEBEL FLARSHEIM MANUFACTURING REPORT: FIELD SERVICE ENGINEER CONFIRMED CUSTOMER'S PROBLEM OF THE GENERATOR CONSOLE TOUCHSCREEN NOT COMING ON WHICH CAUSED THE UNIT NOT TO BE AVAILABLE FOR A FLUORO PROCEDURE. PER SERVICE MANUAL FOR HF SERIES GENERATORS, FSE CHECKED OUT SYSTEM AND REPLACED INTEGRATED CONSOLE AND THEN CHECKED THAT UNIT POWERS UP CORRECTLY. THE CONSOLE TOUCHSCREEN WORKED CORRECTLY BUT DISPLAYED ERROR 15 WHICH IS "NO CURRENT ON FILAMENT" REFERRING TO THE X-RAY TUBE. THE FSE FOUND A FILAMENT OPEN ON X-RAY TUBE AND REPLACED THE TUBE. BOTH PARTS BAD AT THE SAME TIME IS POSSIBLE BUT ALSO COULD HAVE BEEN DUE TO A POWER SPIKE. AFTER INSTALLING X-RAY TUBE, THE FSE CALIBRATED IT IN ACCORDANCE WITH SEDECAL SERVICE MANUAL CALIBRATION SECTION, VERIFIED MAX DOES AT 9.77 R/MIN AND VERIFIED THAT THE SYSTEM OPERATES PER REGULATIONS. UNIT RETURNED TO FULL SERVICE BY THE CUSTOMER.

    Description of Event or Problem · 1

    IN 2008: CUSTOMER REPORTED THAT AT THE BEGINNING OF THE DAY, THAT THE GENERATOR DID NOT COME UP. CUSTOMER REPORTED THAT THEY HAD NO FLUORO CAPABILITIES BUT COULD USE THE PROCEDURE TABLE WHICH STILL WORKED. NO PATIENT INJURY. POTENTIAL OF INJURY WITH THIS EVENT EXISTS.

    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