BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINALY ASSY-REVERSE

    MDR report key: 4223760 · Received August 5, 2014

    Report

    Report Number
    1518293-2014-00083
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 11, 2014
    Manufacturer
    LIEBEL-FLARSHEIM BUSINESS
    Product Code
    IXR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) TROUBLESHOOT FLUORO COMPLAINT, BUT WAS NOT ABLE TO REPRODUCE THE PROBLEM. FSE CHECKED CONNECTIONS, SWITCHES, AND FOOT SWITCH FUNCTIONS AND VERIFIED PROPER OPERATION PER THE MINOR PORTION OF THE HYDRVISION DR SYSTEM SERVICE CHECKLIST. UNIT RETURNED TO FULL SERVICE.

    Description of Event or Problem · 1

    CUSTOMER STATES THE TABLE LOST FLUORO IN THE MIDDLE OF AN UNKNOWN PATIENT PROCEDURE. THE PHYSICIAN WAS ABLE TO FINISH THE PROCEDURE WITH RAD SHOTS. NO FURTHER PATIENT OR PROCEDURAL INFORMATION PROVIDED, OTHER THAN TO SAY THE PATIENT IS FINE. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456537 HUT EXT DR FINALY ASSY-REVERSE IXR LIEBEL-FLARSHEIM BUSINESS HUT EXT DR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK