BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 1366119 · Received March 19, 2009

    Report

    Report Number
    1518293-2009-00069
    Event Type
    Malfunction
    Date Received
    March 19, 2009
    Date of Event
    February 24, 2009
    Report Date
    February 24, 2009
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER TROUBLESHOT THE NO FLUORO ISSUE TO A SPLASH CRASH ERROR. FSE REPAIRED THE SPLASH SHROUD TO PREVENT THE CRASH ERROR FROM REPEATING. UPON FSE CORRECTING THE SPLASH CRASH ERROR PROBLEM, FLUORO WAS RESTORED. FSE CHECKED AND VERIFIED SYSTEM FOR PROPER OPERATION USING HUT DR SERVICE MANUAL 4041004. SYSTEM RETURNED TO FULL SERVICE BY THE CUSTOMER.

    Description of Event or Problem · 1

    ON 3/5: CUSTOMER REPORTS FLUORO FAILED DURING A PATIENT PROCEDURE. NO FURTHER INFORMATION AVAILABLE. PROCEDURE WAS COMPLETED WITH PORTABLE C-ARM FLUORO. 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