BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSMOTION MEDICAL, INC

    MDR report key: 3050539 · Received March 15, 2013

    Report

    Report Number
    3004082462-2013-00002
    Event Type
    Malfunction
    Date Received
    March 15, 2013
    Date of Event
    February 14, 2013
    Report Date
    March 13, 2013
    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 REMEDIAL ACTION WAS TO REPLACE THE PENDANT, WHICH HAD BEEN DAMAGED DUE TO AN UNK CAUSE. THE E-MAIL THAT WAS SENT TO TMM STATED THEY ALSO HAD AN ISSUE WITH THE PENDANTS DRAGGING ON THE GROUND, WHICH WOULD NOT HAVE HELPED. TRANSMOTION MEDICAL, INC IS DESIGNING A NEW PENDANT TO LAUNCH TO IMPROVE OVERALL DURABILITY/QUALITY AND TO PROTECT THE INTERNAL PRINTED CIRCUIT BOARD/ELECTRONICS. THIS SOLUTION IS CURRENTLY UNDERGOING ETL TESTING AND WILL BE IN PLACE IN 2013 FOR PRODUCTION AND SERVICE COMPONENTS.

    Description of Event or Problem · 1

    NO INJURY REPORTED. SUBMITTING BASED ON POTENTIAL. (B)(6) OF (B)(6) (SURGERY CENTER) E-MAILED TMM'S SALES REP STATING THAT THEY WERE GETTING READY FOR AN EYE CASE, AND THE "TOWER" (COLUMN) STARTED MOVING ON ITS OWN. HER CONCERN WAS THAT IT COULD HAVE BEEN A SAFETY ISSUE HAD IT OCCURRED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110133 TRANSMOTION MEDICAL, INC TMM5 MOBILE SURGICAL STRETCHER-CHAIR GBB TRANSMOTION MEDICAL INC. TMM5-XTB 4718

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other