BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSMOTION MEDICAL, INC.

    MDR report key: 4286539 · Received November 20, 2014

    Report

    Report Number
    3004082462-2014-00002
    Event Type
    Malfunction
    Date Received
    November 20, 2014
    Report Date
    November 14, 2014
    Manufacturer
    TRANSMOTION MEDICAL, INC.
    Product Code
    GBB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMMEDIATE ACTION TAKEN WAS TO REPLACE ALL OLDER STYLER PENDANTS WITH NEWLY DESIGNED PENDANTS FOR ALL DEVICES IN THE FACILITY. THERE WAS NOT AN ADVERSE EVENT. NO PT WAS ON THE DEVICE. 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 17 MONTHS AND THERE HAVE BEEN NO REPORTS OF THE NEW PENDANT CAUSING THE DEVICE TO MOVE ON ITS OWN. ADDITIONALLY, IN NOVEMBER 2014, TRANSMOTION MEDICAL, INC LAUNCHED A PRODUCT RECALL DUE TO PREVIOUS CUSTOMER COMPLAINT AND CORRESPONDING MDR DATA.

    Description of Event or Problem · 1

    THERE WAS NO PT EVENT THEREFORE, WE ARE LEAVING THE DATE ABOVE AS "N/A". A SERVICE CALL WAS RECEIVED ON 09/18/2014 TO ADDRESS THE PRODUCT MOVING ON ITS OWN. IT WAS DECIDED ON 10/21/2014, THAT WE SHOULD LAUNCH AN MDR AS GOOD MEASURE FOR REPORTING PURPOSES. THIS MDR IS BEING FILED TO NOTIFY OF THE POTENTIAL FOR INJURY DUE TO THE CHAIR MOVING ON ITS OWN DUE TO A DESIGN ISSUE WITH THE HAND CONTROL PENDANT. AGAIN, THERE WAS NO PT NOR A PT INCIDENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753373 TRANSMOTION MEDICAL, INC. TMM5 MOBILE SURGICAL STRETCHER-CHAIR GBB TRANSMOTION MEDICAL, INC. TMM5-TB 1338, 1355-1362

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE Other