BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N/A

    MDR report key: 20987973 · Received December 20, 2024

    Report

    Report Number
    9615350-2024-00006
    Event Type
    Injury
    Date Received
    December 20, 2024
    Date of Event
    July 27, 2024
    Report Date
    February 27, 2025
    Manufacturer
    MOTION CONCEPTS LP
    Product Code
    ITI
    PMA / PMN Number
    K150574
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE WHEELCHAIR WAS SHIPPED FROM MOTION CONCEPTS TO (B)(4), THE U.S. DISTRIBUTOR FOR MOTION CONCEPTS, ON (B)(4) 2023, IN ACCORDANCE WITH DEALER SPECIFICATIONS. IT WAS SUBSEQUENTLY SOLD TO (B)(4) ON (B)(4) 2023. ACCORDING TO THE DEALER, THE INCIDENT OCCURRED ON JULY 27, 2024, BUT WAS NOT REPORTED TO MOTION CONCEPTS UNTIL DECEMBER 3, 2024. MOTION CONCEPTS HAS REQUESTED TO RETURN THE ALLEGED PART BACK FOR EVALUATION, BUT IT HAD NOT BEEN RECEIVED AT THE TIME OF THIS REPORT. THEREFORE, THE INCIDENT HAS BEEN ASSESSED BASED ON THE INFORMATION PROVIDED BY THE DEALER. THE DEALER REPORTED THAT THE MALFUNCTION OF THE LEGREST RECEIVER WAS FIRST IDENTIFIED IN APRIL 2024 AND WAS BROUGHT TO THEIR ATTENTION BY THE END-USER. UPON INSPECTION, THE DEALER'S TECHNICIAN TIGHTENED THE SCREW ON THE RECEIVER AS A TEMPORARY MEASURE, TO MAKE SURE THE LOCKING MECHANISM WORKS FOR THE LEGREST RECEIVER, INSTEAD OF REPLACING THE RECEIVER KIT. HOWEVER, THEY ACKNOWLEDGED THAT THIS WAS A TEMPORARY SOLUTION, AS THE ISSUE CONTINUED IN SUBSEQUENT MONTHS. THESE MALFUNCTIONS WERE NOT REPORTED TO MOTION CONCEPTS OR OUR DISTRIBUTOR. ON JULY 27, 2024, THE LEGREST SWUNG OPEN AGAIN, DEMONSTRATING THAT THE TEMPORARY FIX WAS INEFFECTIVE IN ADDRESSING THE UNDERLYING PROBLEM WITH THE RECEIVER. MOTION CONCEPTS HAS INCLUDED WARNING STATEMENTS IN THE OWNER'S MANUAL TO HELP PREVENT SIMILAR INCIDENTS. IN THE MOTION CONCEPTS OWNER'S MANUAL, UNDER 2.3.2 'WARNINGS WHEN DRIVING YOUR POWER WHEELCHAIR!', FOLLOWING WARNING STATEMENTS HAS BEEN MENTIONED: "CONTINUED USE OF THE WHEELCHAIR/SEATING SYSTEM WITH DAMAGED PARTS COULD LEAD TO THE WHEELCHAIR MALFUNCTIONING, CAUSING INJURY TO THE USER." IN SECTION 2.5 'GENERAL SAFETY AND HANDLING WARNINGS', THE FOLLOWING STATEMENT WAS MENTIONED. "WARNING! RISK OF SERIOUS INJURY OR DEVICE DAMAGE INCORRECT REPAIR AND/OR SERVICING OF THIS WHEELCHAIR PERFORMED BY USERS/CAREGIVERS OR UNQUALIFIED TECHNICIANS CAN RESULT IN SERIOUS INJURY OR DAMAGE. USERS/CAREGIVERS: DO NOT ATTEMPT TO REPAIR AND/OR SERVICE THIS WHEELCHAIR. REPAIR AND/OR SERVICE OF THIS WHEELCHAIR MUST BE PERFORMED BY A QUALIFIED TECHNICIAN. CONTACT A DEALER OR OUR MOTION CONCEPTS TECHNICAL SERVICE DEPARTMENT FOR FURTHER ASSISTANCE." BASED ON THE AVAILABLE INFORMATION, THE INCIDENT APPEARS TO HAVE OCCURRED DUE TO NON-COMPLIANCE WITH THE WARNING STATEMENTS PROVIDED BY MOTION CONCEPTS. SINCE THE ALLEGED PART HAS NOT BEEN RETURNED FOR EVALUATION, WE ARE UNABLE TO VERIFY THE ISSUE OR CONDUCT A THOROUGH INVESTIGATION. IT IS ALSO POSSIBLE THAT THE RECEIVER WAS NOT FULLY SECURED, WHICH COULD LEAD TO SIMILAR INCIDENTS. ACCORDING TO THE DEALER, THE ALLEGED PARTS WILL BE RETURNED FOR EVALUATION. UPON RECEIVING THE PARTS AND COMPLETING THE EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED TO THE FDA.

    Additional Manufacturer Narrative · 0

    THIS IS A FOLLOW UP REPORT ON MDR 9615350-2024-00006, WHICH WAS SUBMITTED TO THE FDA ON (B)(6)2024. TWO FOLLOW-UP ATTEMPTS WERE MADE TO RETRIEVE THE ALLEGED PART; HOWEVER, THE CUSTOMER DID NOT RETURN THE PART FOR EVALUATION. AS A RESULT, THE COMPLAINT COULD NOT BE VERIFIED. TO ADDRESS THE ISSUE, A REPLACEMENT WAS PROVIDED TO THE CUSTOMER. THE IDENTIFIED CAUSE ON THE INITIAL REPORT, BASED ON THE AVAILABLE INFORMATION, HAS ALREADY BEEN DOCUMENTED IN MOTION CONCEPTS DEVICE RISK ANALYSIS (DRA). SINCE NO FURTHER EVALUATION CAN BE CONDUCTED AT THIS TIME, THE COMPLAINT WILL BE CLOSED.

    Description of Event or Problem · 0

    ON DECEMBER 3, 2024, (B)(4) (DISTRIBUTOR) INFORMED MOTION CONCEPTS LP OF AN INCIDENT INVOLVING ONE OF OUR WHEELCHAIRS. THE PRODUCT HAD BEEN SOLD TO AN END-USER IN THE USA BY A (B)(4), WHO WAS ALSO RESPONSIBLE FOR ITS MAINTENANCE. ACCORDING TO THE DEALER, WHILE THE END-USER WAS LEAVING THEIR HOME, THE RIGHT-SIDE LEGREST SWUNG OPEN, CAUGHT ON THE DOORWAY, AND CAUSED AN INJURY TO THEIR RIGHT ANKLE, RESULTING IN A FRACTURE. IT WAS ALSO REPORTED THAT THE MALFUNCTION OF THE RIGHT LEGREST RECEIVER HAD BEEN IDENTIFIED IN APRIL 2024, BUT THE DEALER'S TECHNICIAN HAD BEEN PERFORMING TEMPORARY FIXES INSTEAD OF REPLACING THE DEFECTIVE PART.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2154459 N/A N/A ITI MOTION CONCEPTS LP 45T-12L-MAXX

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Male Hospitalization| O