BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERED WHEELCAHIR SYSTEM

    MDR report key: 21895427 · Received April 23, 2025

    Report

    Report Number
    9615350-2025-00003
    Event Type
    Injury
    Date Received
    April 23, 2025
    Date of Event
    March 23, 2025
    Report Date
    April 23, 2025
    Manufacturer
    INVACARE CORPORATION
    Product Code
    ITI
    UDI-DI
    00841447114581
    PMA / PMN Number
    K202379
    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, ON 25-JUL-2024. THE SYSTEM WAS SUBSEQUENTLY SOLD TO THE ACCESS MEDICAL IN KAWAIHAE, HAWAII ON AUGUST 02, 2024. THE REPORTED BASE WAS MANUFACTURED BY A THIRD-PARTY MANUFACTURER. THE MANUFACTURER HAS BEEN INFORMED OF THIS INCIDENT BY OUR DISTRIBUTOR. TO ADDRESS THE INCIDENT, MOTION CONCEPTS HAS DECIDED TO REPLACE THE ALLEGED BASE WITH A NEW BASE (SERIAL NUMBER: (B)(6), WHICH WAS SHIPPED ON 04-APR-2025. THE DEALER WILL BE RESPONSIBLE FOR TRANSFERRING THE EXISTING SEATING SYSTEM TO THE NEW BASE. WE HAVE ALSO ADVISED THEM TO CONTACT US SHOULD ANY ISSUES ARISE DURING THE TRANSFER PROCESS. THIS INCIDENT WAS CAUSED BY A MALFUNCTION OF A THIRD-PARTY MANUFACTURED PRODUCT, NOT A MOTION CONCEPTS PRODUCT. SINCE PERSONAL INJURY WAS INVOLVED, WE CONSIDER THIS INCIDENT REPORTABLE.

    Description of Event or Problem · 0

    ON MARCH 28, 2025, MEDBLOC (DISTRIBUTOR) NOTIFIED MOTION CONCEPTS LP OF AN INCIDENT INVOLVING ONE OF OUR WHEELCHAIRS. THE UNIT HAD BEEN SOLD TO AN END-USER IN THE UNITED STATES VIA THE DEALER ACCESS MEDICAL IN KAWAIHAE, HAWAII, WHO IS ALSO RESPONSIBLE FOR ITS MAINTENANCE. THE END-USER HAD BEEN IN COMMUNICATION WITH THE BASE MANUFACTURER, INVACARE, TO SHARE FEEDBACK AND CONCERNS REGARDING THE FUNCTIONALITY OF THE WHEELCHAIR BASE. DURING THIS INTERACTION, THE END-USER REPORTED AN INCIDENT IN WHICH THE WHEELCHAIR UNEXPECTEDLY VEERED TO ONE SIDE WHILE HE WAS REVERSING NEAR HIS BATHROOM SINK. AS A RESULT, HIS ARM BECAME TRAPPED BETWEEN THE WHEELCHAIR'S ARMREST AND THE SINK, CAUSING A CUT AND SIGNIFICANT BRUISING. AT THE TIME OF THE INCIDENT, THE SYSTEM HAD BEEN IN USE FOR APPROXIMATELY EIGHT MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680329 POWERED WHEELCAHIR SYSTEM WHEELCHAIR ITI INVACARE CORPORATION INVACARE RX BASE 00841447114581

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other