BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRANSMOTION MEDICAL, INC.

    MDR report key: 2844985 · Received November 13, 2012

    Report

    Report Number
    3004082462-2012-00004
    Event Type
    Other
    Date Received
    November 13, 2012
    Date of Event
    April 22, 2010
    Report Date
    November 12, 2012
    Manufacturer
    TRANSMOTION MEDICAL INC.
    Product Code
    GBB
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS INSPECTED AND NOTHING AT ALL WAS FOUND TO BE DEFICIENT WITH THE DEVICE. SOME INFORMATION MUST NOT HAVE BEEN FULLY REPORTED, AS THE CHAIR WOULD ONLY TIP IF THE PATIENT'S WEIGHT WAS PUT ON THE HEAD END, AND THE WARNING LABELS WOULD HAVE BEEN IGNORED. SINCE THIS IS A RETROACTIVE REPORT, WE'VE BEEN ABLE TO MONITOR. NO OTHER PATIENT ISSUES HAVE BEEN REPORTED. NO OTHER MODIFICATIONS ARE NEEDED TO THE CHAIR AND THE DEVICE WAS IN-SERVICED AGAIN FOR TRAINING PURPOSES AFTER THE EVENT TO ASSURE THE STAFF DOESN'T RUN INTO THE SAME ISSUE.

    Description of Event or Problem · 1

    THIS IS A RETROACTIVE MDR REPORT RECOMMENDED BY PREVIOUS ON-STE FDA AUDIT. THIS WAS THE INFORMATION THAT WAS PRESENTED IN (B)(6) MEDWATCH VOLUNTARY REPORTING FORM BY (B)(6) ON (B)(6) 2010: PATIENT 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. PATIENT 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 PATIENT REMAINED IN THE CHAIR THROUGHOUT THIS INCIDENT. THE NURSE LIFTED THE BACK OF THE CHAIR BACK UP, SO THAT ALL FOUR WHEELS COULD MAKE FULL CONTACT WITH THE FLOOR AGAIN. THE PATIENT SUFFERED A MINOR ABRASION TO HIS SHOULDER, BUT WAS OTHERWISE UNINJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSMOTION MEDICAL, INC. TMM5 MOBILE SURGICAL STRETCHER-CHAIR GBB TRANSMOTION MEDICAL INC. TMM5-WB 2568

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other