BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CEILING TUBE MOUNT

    MDR report key: 898294 · Received July 2, 2007

    Report

    Report Number
    898294
    Event Type
    Malfunction
    Date Received
    July 2, 2007
    Date of Event
    June 20, 2007
    Report Date
    July 2, 2007
    Manufacturer
    SHIMADZU MEDICAL SYSTEMS
    Product Code
    IYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TUBE STAND DOES NOT EXTEND FOR PROCEDURE THAT REQUIRES PT TO STAND (DOES NOT LOWER ENOUGH). TECHS NOT AWARE THAT MANUALLY RAISING THE TUBE DOES NOT ALLOW THE COUNTER BALANCE TO RETRACT PROPERLY. SERVICE CALLED AND PARTS WERE ORDERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CEILING TUBE MOUNT X-RAY SYSTEM, TUBE MOUNT, CEILING IYB SHIMADZU MEDICAL SYSTEMS CH30GH *

    Patients

    Seq Age Sex Outcome Treatment
    1 *