BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRI W-G, INC. MODEL 630

    MDR report key: 12041695 · Received June 22, 2021

    Report

    Report Number
    1717548-2021-00001
    Event Type
    Malfunction
    Date Received
    June 22, 2021
    Date of Event
    December 1, 2020
    Report Date
    June 21, 2021
    Manufacturer
    TRI W-G, INC
    Product Code
    INQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    A REPORT WAS RECEIVED ON JUNE 1, 2021 FROM FDA REGARDING A REPORT FROM DEC 2020. THE REPORT INDICATED A MALFUCNTION IN A MOTORIZED PATIENT TABLE. PER THE SHIPPING RECORDS THE DEVICE SHIPPED TO THE HOSPITAL ON 02/16/1979. DUE TO THE AGE OF THE DEVICE, THE HOSPITAL HAS BEEN ADVISED TO REPLACE THE DEVICE. THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION, HOWEVER IT IS SAFE TO ASSUME THE AGE OF THE DEVICE IS THE SOURCE OF THE ISSUE. THE DEVICE WAS NOT INTENDED TO BE FUNCTIONAL BEYOND THE REASONABLE ESTIMATED LIFETIME OF THE DEVICE. A COPY OF THE LETTER TO THE HOSPITAL WILL BE PROVIDED IN A FOLLOW-UP REPORT.

    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 CONTIUED 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
    943663 TRI W-G, INC. MODEL 630 POWERED TILT TABLE INQ TRI W-G, INC 630 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR