BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSMOTION MEDICAL, INC

    MDR report key: 4457734 · Received January 23, 2015

    Report

    Report Number
    3004082462-2014-00005
    Event Type
    Malfunction
    Date Received
    January 23, 2015
    Date of Event
    December 11, 2014
    Report Date
    January 22, 2015
    Manufacturer
    TRANSMOTION MEDICAL INC.
    Product Code
    GBB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMMEDIATE ACTION TAKEN WAS TO REPLACE ALL OF THE CUSTOMERS PENDANTS AS THEY HAD A MIX OF NEW AND OLD. TRANSMOTION MEDICAL INC DESIGNED A NEW PENDANT WHICH WAS RELEASED IN 05/2013. THE NEW PENDANT S CONSIDERABLY MORE DURABLE THAN THE OLDER STYLE PENDANTS. THE NEW PENDANT HAS BEEN IN PRODUCTION FOR 18 MONTHS AND THIS IS THE FIRST REPORT OF THE NEW STYLE PENDANT. TMM IS CLOSELY MONITORING FOR ADDITIONAL, VERIFIABLE OCCURRENCES. INSPECTION AND TESTING WAS COMPLETED BY TMM ON THIS SPECIFIC PENDANT RETURNED FROM THE FACILITY. THE TMM PENDANT FUNCTIONED AS EXPECTED AND THE ISSUE COULD NOT BE DUPLICATED. THE ONLY CHANGES WERE THE VISIBLE, EXTERNAL MODIFICATIONS THE FACILITY MADE THEMSELVES TO THE PENDANT TO REMOVE/ADHERE A HOLDING CLIP. NO SIGNIFICANT ENVIRONMENTAL DATA WHEN THE EVENT OCCURRED, WHICH COULD HAVE CONTRIBUTED TO THE MOVEMENT. TMM BELIEVES THIS WAS ACTUALLY ATTRIBUTED TO SKF'S PENDANT, IN WHICH TMM ALREADY HAS AN ONGOING RECALL FOR THE DESCRIBED EVENT.

    Description of Event or Problem · 1

    CUSTOMER NOTIFIED VIA E-MAIL THAT THE DEVICE MOVED FROM A RECLINE POSITION TO STRETCHER POSITION. THERE WAS NO INJURY THAT OCCURRED AND WAS NOTIFYING FOR INFORMATION/SERVICE REQUEST ONLY. NO PT INFO WAS PROVIDED SINCE THERE WAS NOT A REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53830 TRANSMOTION MEDICAL, INC TMM5 SURGICAL STRETCHER-CHAIR GBB TRANSMOTION MEDICAL INC. TMM5-TB 3913

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other