BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSMOTION MEDICAL INC

    MDR report key: 4417561 · Received January 8, 2015

    Report

    Report Number
    3004082462-2014-00004
    Event Type
    Malfunction
    Date Received
    January 8, 2015
    Date of Event
    December 9, 2014
    Report Date
    January 8, 2015
    Manufacturer
    TRANSMOTION MEDICAL INC.
    Product Code
    GBB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. THERE WAS NOT AN ADVERSE EVENT. IT WAS MENTIONED THAT THERE WOULD BE PATIENTS ON THE DEVICE. IT WAS PRESENTED TO TMM AS A GENERAL CONCERN, NOT SPECIFICALLY RELATED TO ANY ONE PT. TRANSMOTION MEDICAL INC HAS DESIGNED A NEW PENDANT WHICH WAS RELEASED IN 05/2013. 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 CAUSE THE DEVICE TO MOVE ON ITS OWN. ADDITIONALLY, IN 11/2014, 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 NOTIFIED THAT TWO OF THEIR CHAIRS WERE MOVING ON THEIR OWN DUE TO A FAULTY PENDANT. NO PT INFO WAS PROVIDED AS IT WAS A GENERAL CONCERN. NO ADVERSE EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17438 TRANSMOTION MEDICAL INC TMM4 MULTIO-PURPOSE STRETCHER-CHAIR GBB TRANSMOTION MEDICAL INC. TMM4-XWB 5379-5380

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other