BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERED WHEELCHAIR SYSTEM

    MDR report key: 6590485 · Received May 25, 2017

    Report

    Report Number
    9615350-2017-00003
    Event Type
    Injury
    Date Received
    May 25, 2017
    Date of Event
    March 3, 2017
    Report Date
    May 25, 2017
    Manufacturer
    MOTION CONCEPTS LP
    Product Code
    ITI
    PMA / PMN Number
    K150574
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SYSTEM WAS ORDERED BY THE DEALER (((B)(4).). THE CRITICAL CLIENT SPECS WERE REQUESTED AND PROVIDED FOR THE CLIENT WEIGHT, THE CLIENT FINISHED KNEE TO HEEL LENGTH, AND TOTAL HEIGHT. THE CLIENT'S BODY TYPE AND SPECIFICATION FOR SEAT SIZE, SEAT HEIGHT, WEIGHT AND DIMENSIONS WERE ALL WITHIN THE ORIGINAL WHEELCHAIR BASE MANUFACTURER'S PRODUCT OFFERING. FROM THE REPORT, WE SEE THAT THE END USER WAS INDEPENDENTLY TRANSFERRING TO THE OTHER CHAIR AND THE TRANSFER ACTIVITY WAS NOT DONE IN PRESENCE OF A QUALIFIED HEALTHCARE PROFESSIONAL. IT IS NOTED THAT THE MOTION CONCEPTS USER MANUAL PROVIDED WITH THIS SYSTEM INCLUDED THE FOLLOWING WARNING: "DETERMINE AND ESTABLISH YOUR PERSONAL SAFETY LIMITS BY PRACTICING BENDING, REACHING AND TRANSFERRING ACTIVITIES IN THE PRESENCE OF A QUALIFIED HEALTHCARE PROFESSIONAL BEFORE ATTEMPTING ACTIVE USE OF THE WHEELCHAIR". HOWEVER, IN THIS CASE IT WAS NOT FOLLOWED BY THE END USER. IT IS CLEAR, THAT THE INCIDENT WAS NOT AS RESULT OF A MALFUNCTION OF THE WHEELCHAIR.

    Description of Event or Problem · 1

    ON 27-APRIL 2017, MOTION CONCEPTS WAS NOTIFIED BY INVACARE CORPORATION OF AN ALLEGED INCIDENT INVOLVING ONE OF OUR TRXULMXT50(CG) SYSTEM. INVACARE WAS INFORMED BY THEIR DEALER, NATIONAL SEATING AND MOBILITY, THAT THE END USER WAS USING HER ROVI WHEN IT JUST STOPPED WORKING. THEN SHE DECIDED TO INDEPENDENTLY TRANSFER INTO HER BACK UP CHAIR. DURING HER TRANSFER, NO CONTACT WAS MADE WITH EITHER WHEELCHAIR AND SHE FELL. HER CAREGIVER, RACHEL, A FRIEND, AND END USER'S MOM WERE PRESENT DURING THE INCIDENT. THE END USER EMPHASIZED THAT THE INJURY WAS HER FAULT. SHE DOES NOT BLAME THE CHAIR FOR IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372880 POWERED WHEELCHAIR SYSTEM WHEELCHAIR ITI MOTION CONCEPTS LP TRX-ULMXT50(CG)

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization