BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERED WHEELCHAIR SYSTEM

    MDR report key: 15789175 · Received November 14, 2022

    Report

    Report Number
    9615350-2022-00009
    Event Type
    Injury
    Date Received
    November 14, 2022
    Date of Event
    September 23, 2022
    Report Date
    November 14, 2022
    Manufacturer
    MOTION CONCEPTS LP
    Product Code
    ITI
    UDI-DI
    00754014711024
    PMA / PMN Number
    K150574
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MENTIONED SYSTEM WAS SHIPPED FROM MOTION CONCEPTS TO MEDBLOC (MOTION CONCEPTS USA IMPORTER/DISTRIBUTOR), AS PER DEALER REQUIREMENTS, (B)(4). THE CAUSE OF THIS INCIDENT HAS BEEN ALREADY CONFIRMED FROM THE END-USER INCIDENT DESCRIPTION, WHICH IS NOT DUE TO ANY SYSTEM MALFUNCTION, BUT AN UNINTENDED/ACCIDENTAL SLIP OF ARMS TO THE SPEED BUTTON, THAT STEERED THE WHEELCHAIR TO LEFT SIDE, WHEN THE SYSTEM WAS OVER THE LIP OF THE RAMP. TO ADDRESS THIS INCIDENT, MOTION COCNEPTS WERE INFORMED THAT THE SYSTEM WILL BE RETURNED BACK TO THE DEALER FOR EVALUATION AND REPAIR. THE INCIDENT OCCURRED NOT DUE TO MOTION CONCEPTS SYSTEM MALFUNCTION BUT, AS A PERSONAL INJURY WAS INVOLVED, MOTION CONCEPTS CONSIDER THIS INCIDENT TO BE REPORTABLE.

    Description of Event or Problem · 0

    ON (B)(6) 2022, MOTION CONCEPTS LP WAS NOTIFIED BY MEDBLOC INC., THAT ONE OF THE DEALERS IN USA (NUMOTION - OMAHA, NE) INFORMED THEM OF AN INCIDENT THAT WAS RELATED TO A MOTION CONCEPTS WHEELCHAIR. THEY NOTIFIED THAT THE END-USER WAS EXITING THE VAN BY GOING DOWN ON A RAMP IN HER WHEELCHAIR, WHEN THE WHEELCHAIR MOVED TO THE LEFT SIDE NEAR THE LIP OF THE RAMP. THE END-USER AND THE WHEELCHAIR FELL ON TO THE GARAGE CEMENT WHEN THE WHEELCHAIR WENT OVER THE LIP OF THE RAMP. THE DEALER ALSO REPORTED THAT THE END-USER MUST HAVE ACCIDENTLY HIT THE SPEED BUTTON, WHILE EXITING THE RAMP, WHICH MADE HER LOSE CONTROL OVER THE WHEELCHAIR. THE END-USER'S LEFT LEG HAD SCRAPED ELBOW, FRACTURED FEMUR AND TIBIA ON KNEE AND BROKEN PLATEAU. THEY ALSO REPORTED THAT THE END-USER HAD PAIN IN RIGHT SHIN AND BRUISE IN RIGHT FOOT AND ANKLE DUE TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1783777 POWERED WHEELCHAIR SYSTEM WHEELCHAIR ITI MOTION CONCEPTS LP RS-12L-MAXX 00754014711024

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Other