BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVIVA STORM RX

    MDR report key: 22978551 · Received September 5, 2025

    Report

    Report Number
    1525712-2025-00011
    Event Type
    Injury
    Date Received
    September 5, 2025
    Date of Event
    June 15, 2025
    Report Date
    September 5, 2025
    Manufacturer
    INVACARE TAYLOR ST.
    Product Code
    ITI
    UDI-DI
    00841447114581
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS ISSUE IS RELATED TO A 1-YEAR-OLD SRX-20MP (AVIVA RX) POWER WHEELCHAIR. THE POWERED BASE OF THIS DEVICE WAS MANUFACTURED BY INVACARE. MOTION CONCEPTS INSTALLED THE SEATING SYSTEM. MOTION CONCEPTS CONFIRMED THAT THEY PROVIDED THEIR CASTER/FORK REPLACEMENT KIT TO THE DEALER ON 1/28/2025, RELATED TO A PREVIOUS CASTER ISSUE. AFTER EVALUATION OF THE INFORMATION AND PICTURE MADE AVAILABLE, MOTION CONCEPTS STATED THIS APPEARS TO BE RELATED TO AN INSTALLATION ERROR BY THE DEALER. MOTION CONCEPTS IS TO ADDRESS THIS ERROR WITH THE DEALER. MOTION CONCEPTS ALSO CONFIRMED THAT ALL THE SEATING SYSTEMS THEY SELL HAVE THE POSTURAL BELT INSTALLED. THEY CONFIRMED WITH THE DEALER THAT THE END USER WAS NOT WEARING A POSTURAL BELT AT THE TIME OF THE INCIDENT. ALSO, IT WAS NOTED THAT ONE SIDE OF THE WHEELCHAIR WOULD NEED TO BE LIFTED BY 5 INCHES OR MORE FOR THE CASTERS TO DETACH FROM THE SYSTEM. IT IS UNKNOWN WHAT MAY HAVE CONTRIBUTED TO THE CHAIR BEING OFF THE GROUND FAR ENOUGH FOR THE CASTER TO DETACH WITH THE INFORMATION AVAILABLE. MOTION CONCEPTS IS WORKING WITH THE DEALER AND END USER FOR A SOLUTION. AT THE TIME OF THIS REPORT THE END USER WILL NOT RELEASE THE CHAIR AND DOES NOT WANT ANOTHER SYSTEM DUE TO THE TRAUMATIC EVENT. NO RETURN OF THE DEVICE IS EXPECTED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL RECORD WILL BE SENT ACCORDINGLY. THE OWNER'S MANUAL FOR THE AVIVA RX INCLUDES THE FOLLOWING: NOT WEARING YOUR SEAT POSITIONING STRAP COULD RESULT IN DEATH OR SERIOUS INJURY. ALWAYS WEAR YOUR SEAT POSITIONING STRAP. YOUR SEAT POSITIONING STRAP HELPS REDUCE THE POSSIBILITY OF A FALL FROM THE WHEELCHAIR. IF SIGNS OF WEAR APPEAR, SEAT POSITIONING STRAP MUST BE REPLACED IMMEDIATELY.

    Description of Event or Problem · 0

    WHILE USING THE AVIVA RX POWERCHAIR ON A FLAT SURFACE, THE END USER TURNED APPROX. 30 DEGREES TO ACCESS A CURB CUTOUT TO MANEUVER FROM THE STREET TO THE SIDEWALK. THE LEFT FRONT WHEEL AND CASTER COMPONENTS CAME OFF THE CHAIR ENTIRELY. THIS RESULTED IN THE CHAIR TO TIP AND FALL TO THE LEFT. THE END USER LANDED FACE FIRST ON THE PAVEMENT BREAKING THE CHAIRS ARMREST WITH LEFT SIDE OF HER BODY. THE END USER SUSTAINED A BUMP ON HER FOREHEAD, BROKEN GLASSES LACERATING THE BRIDGE OF HER NOSE AND HER JAW BEING SCRAPED. THE END USERS FACE HAD MULTIPLE CUTS, SWELLING AND BRUISING. HER LEFT HAND WAS SUSPECTED OF FRACTURE, SO SHE WAS TAKEN TO THE HOSPITAL FOR EVALUATION. A CT SCAN OF HEAD/NECK WAS CLEAR, AND X-RAYS OF HER HAND SHOWED NO BREAKS. THERE WAS A BUMP ON HER LEFT HAND AND CONTINUOUS PAIN, LIMITING USE OF HER HAND AT THE TIME OF COMMUNICATING THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2224899 AVIVA STORM RX POWERED WHEELCHAIR ITI INVACARE TAYLOR ST. NA:SRX-20MP 00841447114581

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization