BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRANSMOTION MEDICAL, INC.

    MDR report key: 2493875 · Received February 3, 2012

    Report

    Report Number
    3004082462-2012-00001
    Event Type
    Other
    Date Received
    February 3, 2012
    Date of Event
    January 5, 2012
    Report Date
    January 30, 2012
    Product Code
    GBB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A FULL WRITTEN REPORT WAS REQUESTED FROM THE FACILITY REGARDING THE INCIDENT ON TWO OCCASIONS (B)(6) 2012 AND WE HAVE YET TO RECEIVE. THEREFORE, THE DETAILS OF THE AGE/WEIGHT OF THE PATIENT ARE NOT EXACTLY KNOWN AS DIFFERENT ANSWERS WERE PROVIDED FROM DIFFERENT MEMBERS OF THE STAFF. AN INITIAL INSPECTION WAS CONDUCTED BY (B)(4) (TMM SALES REPRESENTATIVE) ON (B)(4) 2012, ALONG WITH (B)(4), AND NOTHING WAS FOUND TO BE WRONG WITH THE CHAIR. THE CHAIR WAS INSPECTED BY (B)(4) ON (B)(4) 2012, WHILE ON-SITE AT (B)(6) MEMORIAL. THE CHAIR WAS FULLY FUNCTIONAL AND NO ISSUE WAS FOUND WITH THE BACK ACTUATOR. THE ONLY POSSIBLY SCENARIO IS THAT THE PATIENT OR CAREGIVER ACCIDENTALLY PULLED THIS LEVER CAUSING THE BACK SECTION TO DROP AS DESIGNED. THE PATIENT WAS NOT WEARING THE SAFETY STRAP. AN INSPECTION LETTER WAS SENT TO (B)(4) VIA EMAIL ON (B)(4) 2012, STATING THE CHAIR WAS FULLY FUNCTIONAL.

    Description of Event or Problem · 1

    THE PRODUCT WAS IN A RECLINE POSITION AND IT SUDDENLY WENT INTO TRENDELENBURG POSITION. THE PATIENT SLID DOWN THE SURFACE AND HIT HER HEAD AGAINST THE WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSMOTION MEDICAL, INC. TMM4 SERIES MULTI-PURPOSE STRETCHER/CHAI GBB TMM4-XWTRFB 3990

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR