BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSMOTION MEDICAL INC.

    MDR report key: 4209316 · Received September 18, 2014

    Report

    Report Number
    3004082462-2014-00001
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 17, 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 STYLE PENDANTS WITH NEWLY DESIGNED PENDANTS FOR ALL DEVICES IN THE FACILITY. EARLIER REPORTS FROM THIS FACILITY INDICATE THAT THE PENDANTS WERE BEING DRUG ON THE GROUND WHICH COULD DAMAGE THE PENDANT AND CAUSE A MALFUNCTION. THE DATE OF THE INCIDENT IS UNK AND DOCUMENTED AS THE DATE THAT THE SALES REP WAS INFORMED OF THE INCIDENT. (B)(6) DID NOT PROVIDE THE SPECIFIC DATE OF THE INCIDENT. (B)(6). 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 A TOTAL OF APPROX (B)(4) PENDANTS ARE CURRENTLY IN THE FIELD. THERE HAVE BEEN NO REPORTS OF THE NEW PENDANT CAUSING THE DEVICE TO MOVE ON ITS OWN.

    Description of Event or Problem · 1

    (B)(6) CONTACTED HER TMM SALES REP (B)(4) STATING THAT DURING AN EYE PROCEDURE, THE TMM5 STRETCHER-CHAIR STARTED MOVING DOWN ON ITS OWN. (B)(6) DID NOT INDICATE IF THE MOVEMENT WAS IN THE BACK SECTION OR THE COLUMN OF THE CHAIR. (B)(6) IS CONCERNED THAT THE OTHER PENDANTS ON THE OTHER CHAIRS IN THE FACILITY WILL MALFUNCTION IN THE SAME MANNER INJURING A PATIENT. (B)(6) WAS ASKED FOR DETAILS ABOUT THE PATIENT AND THE INCIDENT BUT THIS INFO WAS NOT DOCUMENTED BY THE FACILITY AT THE TIME OF THE INCIDENT. (B)(6) COULD NOT PROVIDE ANY OTHER INFO OTHER THAN THE CHAIR MOVED DOWN ON ITS OWN DURING THE PROCEDURE WITH THE PENDANT HANGING OR LAYING ON THE CHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580327 TRANSMOTION MEDICAL INC. TMM5 MOBILE STRETCHER-CHAIR GBB TRANSMOTION MEDICAL INC. TMM5-XTB 4717

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other