BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-STANDARD

    MDR report key: 2093527 · Received April 5, 2011

    Report

    Report Number
    1518293-2011-00065
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 15, 2011
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TECH SUPPORT TROUBLESHOT WITH CUSTOMER REGARDING THE REPORT OF, TUBE NOT EXTENDED, IMAGE INTENSIFIER NOT ALIGNED AND, A CHECK COLLIMATOR MESSAGE. TECH SUPPORT ADVISED BIOMED ON A LIST OF WHAT TO CHECK WHEN HE GOT ONSITE. FACILITY BIOMED CALLED AND STATED, HE RESEATED THE TOWER INTERFACE BOARD WHICH RESOLVED THE ISSUE. THE SYSTEM WAS NOW FULLY FUNCTIONAL.

    Description of Event or Problem · 1

    ON (B)(6): CUSTOMER REPORTS SYSTEM FAILURE, X-RAY TUBE NOT EXTENDED AND CHECK COLLIMATOR HAPPENED DURING PATIENT PROCEDURE. PATIENT WAS MOVED TO ANOTHER ROOM AND PROCEDURE WAS COMPLETED WITHOUT INCIDENT. NO PATIENT INJURY REPORT. TYPE OF PROCEDURE AND PATIENT GENDER/AGE WERE NOT AVAILABLE.

    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