BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERED WHEELCHAIR SYSTEM

    MDR report key: 15428344 · Received September 15, 2022

    Report

    Report Number
    9615350-2022-00007
    Event Type
    Injury
    Date Received
    September 15, 2022
    Date of Event
    August 16, 2022
    Report Date
    September 15, 2022
    Manufacturer
    MOTION CONCEPTS LP
    Product Code
    ITI
    UDI-DI
    00754014710065
    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 (B)(4), AS PER DEALER REQUIREMENTS, ON 09-MAR-2022 AND THEN WAS SOLD TO (B)(4) ON 15-MAR-2022. 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, THAT STEERED THE JOYSTICK AND THE SYSTEM TO THE POOL. AS THE MENTIONED SYSTEM HAS STOPPED WORKING AFTER THE INCIDENT, THE DEALER RETURNED THE WHEELCHAIR BACK FROM THE END-USER FOR EVALUATION. MOTION CONCEPTS HAS INFORMED THE DEALER THAT ALL THE ELECTRICAL AND MECHANICAL COMPONENTS IN THE SYSTEM NEEDS TO BE REPLACED, AS IT ALL WENT UNDER WATER OR ELSE IT WOULD BE BETTER AND SAFE TO REPLACE THE ENTIRE SYSTEM. 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 (B)(4), THAT ONE OF THE DEALERS IN USA (B)(4) INFORMED THEM OF AN INCIDENT THAT WAS RELATED TO A MOTION CONCEPTS WHEELCHAIR. THEY NOTIFIED THAT THE END-USER WAS DRIVING HIS WHEELCHAIR ALONGSIDE AN INGROUND SWIMMING POOL AT HIS APARTMENT COMPLEX AND HIS ARMS SLIPPED WHICH CAUSED HIM TO STEER THE JOYSTICK TO THE RIGHT INTO THE FOUR FEET DEEP SHALLOW END OF THE POOL. THEY ALSO REPORTED THAT THE END-USER AND THE SYSTEM WAS UNDER WATER FOR AROUND 10 SECONDS AND HIS FRIENDS, WHO WERE WITH HIM AT THE TIME OF THE INCIDENT, GOT INTO THE POOL AND GOT THE END-USER AND THE SYSTEM OUT FROM POOL. THE END-USER HAD SOME BRUISING ON HIS CHIN, ELBOW, AND KNEES DUE TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271036 POWERED WHEELCHAIR SYSTEM WHEELCHAIR ITI MOTION CONCEPTS LP 45T-12L-RESR-MAXX 00754014710065

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other