BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-STANDARD

    MDR report key: 1864880 · Received September 28, 2010

    Report

    Report Number
    1518293-2010-00127
    Event Type
    Malfunction
    Date Received
    September 28, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 3, 2010
    Manufacturer
    LIEBEL-FLARSHEIM CO
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER TROUBLESHOT AND FOUND THE X-RAY FOOTSWITCH RAD IMAGING/SPOT EXPOSURES SWITCH WORKED BUT NOT THE FLUORO SWITCH. FSE REPLACED THE X-RAY FOOTSWITCH AND COMPLETED OPERATIONAL CHECKS AND VERIFICATION PER SERVICE CHECKLIST. UNIT WAS RETURNED TO SERVICE BY THE CUSTOMER.

    Description of Event or Problem · 1

    ON (B)(6), CUSTOMER REPORTS FLUORO FAILED DURING A URETEROSCOPY PROCEDURE. PROCEDURE WAS COMPLETED USING RAD IMAGING. CUSTOMER PROVIDED NO PT OR PROCEDURAL INFO OTHER THAN NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUT EXT DR FINAL ASSY-STANDARD UROLOGY SUITE KQS LIEBEL-FLARSHEIM CO HUT EXT DR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK