BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 2497257 · Received March 13, 2012

    Report

    Report Number
    1518293-2012-00045
    Event Type
    Malfunction
    Date Received
    March 13, 2012
    Date of Event
    February 28, 2012
    Report Date
    March 13, 2012
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    IXR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN TECH SUPPORT ADVISED CUSTOMER TO TRY TO TUBE WARM-UP AS WELL AS FLUORO AND RAD. CUSTOMER TRIED AND REPORTED TUBE WARM-UP AND FLUORO WERE WORKING, HOWEVER THEY HAD NO RAD SHOT. TECH SUPPORT INSTRUCTED CUSTOMER TO CHECK PATIENT FILE STATUS. CUSTOMER REPORTED THEY FOUND PATIENT FILE WAS NOT OPENED. CUSTOMER OPENED PATIENT FILE AND REPORTS RAD WAS FUNCTIONING AND PERFORMING AS EXPECTED. TECH SUPPORT ALSO VERIFIED WITH THE CUSTOMER THAT THE RIGHT SIDE MONITOR HAD BEEN SET UP BY CUSTOMER FOR CAMERA IMAGES; THEREFORE, NO RAD/FLUORO WOULD BE EXPECTED THERE. CUSTOMER REPORTS SYSTEM WAS NOW WORKING. SYSTEM RETURNED TO FULL SERVICE BY CUSTOMER.

    Description of Event or Problem · 1

    MARCH 2: CUSTOMER REPORTS STAFF WERE PERFORMING AN UNDETERMINED UROLOGY PROCEDURE WHEN FLUORO AND RAD IMAGING FAILED. CUSTOMER UNABLE TO PROVIDE PATIENT OR PROCEDURAL INFORMATION, OTHER THAN TO SAY THE PROCEDURE WAS COMPLETED AND PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUT EXT DR FINAL ASSY-REVERSE IXR LIEBEL-FLARSHEIM CO. HUT EXT DR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK