BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHEELCHAIR

    MDR report key: 15925442 · Received December 5, 2022

    Report

    Report Number
    MW5113653
    Event Type
    Malfunction
    Date Received
    December 5, 2022
    Date of Event
    September 29, 2022
    Report Date
    December 5, 2022
    Manufacturer
    MOTION COMPOSITES
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    REPORTER CALLED FROM MFR TO REPORT THAT THE DEALER HAD REPORTED AN END USER WAS SITTING IN THE WHEELCHAIR WHILE BEING TRANSPORTED IN A MOTOR VEHICLE, WHILE VEHICLE WAS IN MOVEMENT BOTH CARBON BACKING BROKE AND THE END USER FELL BACKWARDS. REPORTER STATED THE END USER WAS BROUGHT TO THE HOSPITAL FOLLOWING THE INCIDENT AND WAS DISCHARGED THE SAME DAY. REPORTER STATED NO SERIOUS INJURY WAS REPORTED AND THAT AN INVESTIGATION WILL BE COMPLETED AT THE MANUFACTURING FACILITY ONCE THE DEVICE IS RETURNED. REPORTER STATED THIS IS THE FIRST INCIDENT REPORTED WITH THIS TYPE OF FAILURE. REPORTER STATED THE MOTION COMPOSITES MANUAL RECOMMENDS THE USER SHOULD TRANSFER TO MODEL VEHICLE SEAT AND USE THE VEHICLE INSTALLER SYSTEM WHEN FEASIBLE. REPORTER STATED THAT MOTION COMPOSITES OFFERS AN OCCUPIED ANCHOR KIT CONFORMING TO REQUIREMENTS OF RETNA WC4 2017 VERSION SECTION 19 FOR OCCUPIED TRANSIT TO BE USED WITH THEIR WHEELCHAIR AND THAT IT IS ONLY OFFERED AS A FACTORY INSTALLED OPTION. REPORTER STATED IN RELATION OF THE REPORTED INCIDENT A REVIEW OF RECORDS ALLOWED THEM TO CONCLUDE THAT NO MOTION COMPOSITE ANCHOR KIT WAS INSTALLED BY MOTION COMPOSITE ON THIS DEVICE. REPORTER STATED THIS CASE IS NOT AN ADVERSE EVENT BUT IS BEING REPORTED OUT OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313913 WHEELCHAIR WHEELCHAIR, MECHANICAL IOR MOTION COMPOSITES HELIO

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male