BEUDAMED
    FDA Adverse Event Death Summary report: N

    POWERED WHEELCHAIR SYSTEM

    MDR report key: 21800825 · Received April 8, 2025

    Report

    Report Number
    9615350-2025-00002
    Event Type
    Death
    Date Received
    April 8, 2025
    Date of Event
    February 5, 2025
    Report Date
    April 8, 2025
    Manufacturer
    MOTION CONCEPTS LP
    Product Code
    ITI
    PMA / PMN Number
    K182995
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE MENTIONED SYSTEM WAS SHIPPED FROM MOTION CONCEPTS TO (B)(4) ((B)(4) IMPORTER/DISTRIBUTOR), AS PER DEALER REQUIREMENTS, ON 18-OCT-2024. THE SYSTEM WAS SUBSEQUENTLY SOLD TO THE (B)(6) ON NOVEMBER 19, 2024. A REVIEW OF THE DEVICE HISTORY CONFIRMED THAT NO ISSUES OR CONCERNS HAD BEEN REPORTED BY EITHER THE DEALER OR THE END-USER, PRIOR TO THE REPORTED INCIDENT. MOTION CONCEPTS BECAME AWARE OF THE INCIDENT WHEN AN (B)(6) REPRESENTATIVE VISITED THE END-USER'S RESIDENCE, BY SCHEDULED APPOINTMENT, TO RETURN THE USER'S PREVIOUS WHEELCHAIR. DURING THE VISIT, THE END-USER'S NIECE INFORMED THE REPRESENTATIVE ABOUT THE INCIDENT AND SPECIFICALLY REQUESTED THAT THE SYSTEM INVOLVED IN THE INCIDENT NOT BE HANDLED. DESPITE MOTION CONCEPTS REQUESTING FOR FURTHER DETAILS, NO ADDITIONAL INFORMATION WAS PROVIDED. THIS LACK OF INFORMATION HAS LIMITED OUR ABILITY TO PERFORM AN EVALUATION OR DETERMINE WHETHER THE INCIDENT WAS RELATED TO A SYSTEM MALFUNCTION. THE (B)(6) REPRESENTATIVE CAPTURED SEVERAL PHOTOS OF THE WHEELCHAIR RAMP AT THE RESIDENCE, WHICH WERE SHARED WITH MOTION CONCEPTS WHEN (B)(6) REPORTED THE INCIDENT. UPON A REVIEW OF THE IMAGES, IT APPEARS THAT THE RAMP WAS CONSTRUCTED FROM ORIENTED STRAND BOARD AND WAS LACKING A CURB RAMPS OR CURB CUTS, WHICH IS AN ESSENTIAL DESIGN SAFEGUARD TO HELP TO PREVENT A WHEELCHAIR FROM ACCIDENTALLY TIPPING OVER OR DRIVING OFF THE EDGE. BASED ON THE INFORMATION MADE AVAILABLE TO MOTION CONCEPTS, THERE IS NO INDICATION THAT THERE WAS A SYSTEM MALFUNCTION. HOWEVER, SINCE THE INCIDENT INVOLVED ONE OF OUR WHEELCHAIRS, WE ARE CONSIDERING THIS AS A REPORTABLE EVENT.

    Description of Event or Problem · 0

    ON MARCH 12, 2025, INVACARE NOTIFIED MOTION CONCEPTS LP OF A INCIDENT INVOLVING ONE OF OUR WHEELCHAIRS, IN WHICH THE END-USER TRAGICALLY PASSED AWAY FROM A HEART ATTACK, AFTER BECOMING PINNED UNDER THE WEIGHT OF THE CHAIR. THE PRODUCT HAD BEEN SOLD TO THE END-USER IN THE UNITED STATES THROUGH THE VAMC - SALISBURY, NC (659/121). AS REPORTED BY INVACARE, THE INCIDENT TOOK PLACE WHILE THE END-USER WAS ATTEMPTING TO DRIVE THE WHEELCHAIR UP A RAMP LEADING INTO HIS RESIDENCE. DURING THE PROCESS, THE WHEELCHAIR REPORTEDLY TIPPED OVER, PINNING THE USER UNDERNEATH. THE END-USER SUFFERED A HEART ATTACK AND SUBSEQUENTLY PASSED AWAY. THE END-USER'S NIECE, WHO WAS PRESENT AT THE TIME OF THE INCIDENT, CALLED EMERGENCY SERVICES. IT WAS FURTHER REPORTED THAT AN AUTOPSY WAS CONDUCTED. AT THE TIME OF THE EVENT, THE SYSTEM HAD BEEN IN USE FOR APPROXIMATELY FIVE MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740941 POWERED WHEELCHAIR SYSTEM WHEELCHAIR ITI MOTION CONCEPTS LP BPPS-T-10L-RESR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Death