BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 2093407 · Received April 12, 2011

    Report

    Report Number
    1518293-2011-00067
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 22, 2011
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TECH SUPPORT TROUBLESHOT WITH CUSTOMER WHO REPORTED THEY RECEIVED A MESSAGE AT THE TABLE THAT THE SYSTEM WAS MISALIGNED, AND THE X-RAY WAS DISABLED, AND TO "PRESS IMAGE." TECH SUPPORT ADVISED CUSTOMER TO USE THE HANDSWITCH MOVE TABLE FULLY TO THE FOOT END AND FULLY TO HEAD END TO RE-ALIGN. HOWEVER, CUSTOMER WANTED TO DO THIS AFTER THE CURRENT PT WAS COMPLETED. TECH SUPPORT F/U; TECHNOLOGIST STATES THE RE-ALIGNMENT MOVEMENTS WERE PERFORMED AND THE SYSTEM IS NOW WORKING NORMALLY, THE SYSTEM IS OK. IF A MIS-ALIGNMENT IS DETECTED BY THE TABLE SYSTEM, A SAFETY INTERLOCK WILL PREVENT FLUORO. THIS MESSAGE IS THEN SHOWN ON THE TABLE MONITOR ALONG WITH THE PROMPT TO "PRESS IMAGE." PRESSING "IMAGE" ON THE HANDSWITCH GETS THE TABLE BACK INTO CORRECT ALIGNMENT AND RELEASES THE SAFETY INTERLOCK. THIS IS DESCRIBED IN THE OPERATIONS MANUAL AS WELL AS THE METHOD TO RE-ALIGN THE TUBE AND THE IMAGE INTENSIFIER SO THE PROCEDURE CAN PROCEED.

    Description of Event or Problem · 1

    ON (B)(6): CUSTOMER REPORTS THEY COULD NOT FLUORO. THE CUSTOMER SAID THEY RECEIVED A MESSAGE AT THE TABLE THAT THE SYSTEM WAS MISALIGNED, AND THE X-RAY WAS DISABLED. THEY MOVED A C-ARM INTO THE SUITE TO PROVIDE FLUORO. ON (B)(6): CUSTOMER REPORTS PHYSICIAN PERFORMING A LASER STONE REMOVAL PROCEDURE WHEN FLUORO FAILED. CUSTOMER PROVIDED NO FURTHER INFO ON THE PROCEDURE OR PT, OTHER THAN TO SAY ALL WAS COMPLETED USING A PORTABLE FLUORO C-ARM. 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