BEUDAMED
    FDA Adverse Event Summary report: N

    TRANSMOTION MEDICAL, INC.

    MDR report key: 4600679 · Received March 10, 2015

    Report

    Report Number
    3004082462-2015-00001
    Date Received
    March 10, 2015
    Date of Event
    February 12, 2015
    Report Date
    March 10, 2015
    Manufacturer
    TRANSMOTION MEDICAL INC.
    Product Code
    GBB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMMEDIATE ACTION TAKEN WAS TO REPLACE OLDER STYLE PENDANTS WITH NEWLY DESIGNED PENDANTS FOR ALL DEVICES IN THE FACILITY UNDER THE CURRENT VOLUNTARY RECALL. THERE WAS NOT AN ADVERSE EVENT. THE CUSTOMER ORIGINALLY SAID THAT THE CHAIR MOVED ON ITS OWN. THEN LATER IN AN EMAIL, SAID THE CHAIR MOVED DURING A PROCEDURE "NO INJURIES CAUSED AT ALL." TRANSMOTION MEDICAL INC HAS DESIGNED A NEW PENDANT WHICH WAS RELEASED IN MAY OF 2013. THE NEW PENDANT IS CONSIDERABLY MORE DURABLE THAN THE OLDER STYLE PENDANTS. THE NEW PENDANT HAS BEEN IN PRODUCTION FOR 22 MONTHS AND THERE HAS BEEN ONE CUSTOMER CLAIM THAT THE NEW PENDANT CAUSED THE CHAIR TO MOVE ON ITS OWN BUT THIS COULD NOT BE CONFIRMED. IN NOVEMBER 2014, TRANSMOTION MEDICAL, INC LAUNCHED A PRODUCT RECALL DUE TO PREVIOUS CUSTOMER COMPLAINT AND CORRESPONDING MDR DATA. THIS MDR IS FOR VOLUNTARY REPORTING PURPOSES ONLY.

    Description of Event or Problem · 1

    CUSTOMER CALLED TECHNICAL SERVICE LINE AND SAID THAT THE CHAIR MOVED ON ITS OWN WITHOUT PUSHING ANY OF THE BUTTONS ON THE PENDANT. EMAIL RECEIVED FROM (B)(6) SAID THE CHAIR MOVED DURING A PROCEDURE BUT THERE WERE NO INJURIES CAUSED AT ALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163987 TRANSMOTION MEDICAL, INC. TMM5 SURGICAL STRETCHER-CHAIR GBB TRANSMOTION MEDICAL INC. TMM5-TB 0435

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other