BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-STANDARD

    MDR report key: 2040327 · Received February 15, 2011

    Report

    Report Number
    1518293-2011-00041
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 17, 2011
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    TECH SUPPORT TROUBLESHOT WITH CUSTOMER AND FOUND THIS WAS NOT A NO FLUORO ISSUE, BUT RATHER A LOW FLUORO, SET AT 40KV RESULTED IN THE BLACK IMAGES. THE CUSTOMER HIT THE DEFAULT TECHNIQUE BEFORE TECH SUPPORT COULD DETERMINE IF THE SEDECAL WAS IN AN AUTOMATIC OR MANUAL EXPOSURE CONTROL. CUSTOMER PLACED LEAD APRONS ON AND OFF THE TABLE AND THE FLUORO KV WAS DRIVING UP AND DOWN WITH NORMAL FLUORO IMAGE. THE GENERATOR WAS INADVERTENTLY IN MANUAL MODE AT 40KV. TECH SUPPORT FOLLOW UP; CUSTOMER REPORTS THE SYSTEM IS FULLY FUNCTIONAL.

    Description of Event or Problem · 1

    (B)(6): CUSTOMER REPORTS PATIENT WAS ON THE TABLE, FLUORO IMAGE IS BLACK, BUT DIGITAL RAD SHOTS ARE O.K. PATIENT CASE WAS SUCCESSFULLY FINISHED WITH DIGITAL RAD EXPOSURES. CUSTOMER PROVIDED NO PATIENT OR PROCEDURAL INFORMATION OTHER THAN TO SAY NO REPORTED INJURY. PROCEDURE COMPLETED.

    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