BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSMOTION

    MDR report key: 2571292 · Received May 14, 2010

    Report

    Report Number
    2571292
    Event Type
    Malfunction
    Date Received
    May 14, 2010
    Date of Event
    April 22, 2010
    Report Date
    May 7, 2010
    Manufacturer
    TRANSMOTION MEDICAL INC.
    Product Code
    GBB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT CHANGED INTO GOWN AND GOT INTO STRETCHER. STRETCHER BACK WAS INCLINED 30 DEGREES, FOOT REST PORTION WAS FLAT, 0 DEGREE ANGLE FROM THE SEAT PORTION. PT SAT DOWN ON THE STRETCHER, WAS FULLY LYING DOWN COOPERATIVELY. AT THIS POINT, THE STRETCHER APPARENTLY TILTED ON THE TWO HEADWARD WHEELS, THE TWO FOOTWARD WHEELS CAME UP OFF THE GROUND, AND THE BACKREST OF THE STRETCHER MADE CONTACT WITH EITHER THE FLOOR OR THE BACK OF THE WALL IN THE PRE-OP BAY. THE PT REMAINED IN THE STRETCHER THROUGHOUT THIS INCIDENT. THE NURSE LIFTED THE BACK OF THE STRETCHER BACK UP SO THAT ALL FOUR WHEELS COULD MAKE FULL CONTACT WITH THE FLOOR AGAIN. THE PT'S SUFFERED A MINOR ABRASION TO HIS SHOULDER BUT WAS OTHERWISE UNINJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSMOTION TRANSMOTION TMM5 SURGI-CHAIR -24V WIDE GBB TRANSMOTION MEDICAL INC. TMM5

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR