BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 2063255 · Received March 22, 2011

    Report

    Report Number
    1518293-2011-00051
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 22, 2011
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER TROUBLESHOT AND FOUND THE COLLIMATOR WAS NOT HOMING PROPERLY, CAUSING THE FLUORO NOT TO WORK CONSISTENTLY. FSE CLEANED THE MECHANISM INSIDE THE COLLIMATOR AND TESTED ITS PERFORMANCE. FSE CHECKED FOR PROPER OPERATION PER SERVICE CHECKLIST AND SYSTEM RETURNED TO FULL SERVICE BY THE CUSTOMER.

    Description of Event or Problem · 1

    ON (B)(6): CUSTOMER REPORTS THAT WHILE A PATIENT WAS UNDERGOING AN ERCP PROCEDURE, FLUORO WAS TURNING ON AND OFF. STAFF BROUGHT A PORTABLE FLUORO C-ARM TO COMPLETE PROCEDURE. NO PATIENT INJURY REPORTED. PATIENT AGE AND GENDER NOT PROVIDED.

    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