BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TILT TABLE 630

    MDR report key: 11789613 · Received May 7, 2021

    Report

    Report Number
    11789613
    Event Type
    Malfunction
    Date Received
    May 7, 2021
    Date of Event
    December 1, 2020
    Report Date
    December 17, 2020
    Manufacturer
    TRI W-G INC.
    Product Code
    LGX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE USE OF THE TILT TABLE TO ASSESS PATIENT FOR POSITIONAL VERTIGO, WIRED REMOTE TO CONTROL UP/DOWN MOVEMENT BECAME GLITCHY AND WOULD MOVE TABLE IN VARYING UP/DOWN POSITIONS - EVEN IF NOT TOUCHED. TABLE CONTINUED TO INVERT PATIENT BEYOND DESIRED POSITION AND PATIENT WAS ASSISTED INTO A SEATED POSITION IN CHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690669 TILT TABLE 630 TABLE, EXAMINATION, MEDICAL, POWERED LGX TRI W-G INC. HLT8 630

    Patients

    Seq Age Sex Outcome Treatment
    1 34675 DA Other