BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERED WHEELCHAIR SYSTEM

    MDR report key: 14719369 · Received June 16, 2022

    Report

    Report Number
    9615350-2022-00004
    Event Type
    Injury
    Date Received
    June 16, 2022
    Date of Event
    May 2, 2022
    Report Date
    June 16, 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)(6), AS PER DEALER REQUIREMENTS, ON (B)(6) 2019 AND THEN WAS SOLD TO (B)(6) HEALTH CARE, (B)(6). ON (B)(6) 2019. BUT THE WHEELCHAIR WAS MAINTAINED BY (B)(6). THE DEALER REPORTED THAT THE END USER GOT PRESSURE SORES ON HER HIP AND BOTTOM OF HER HEEL THAT WAS IN A FOOTBOX, AS THE CUSHION ON THE SEATING SYSTEM SLIPPED FORWARD. DURING THE EVALUATION, IT WAS ALSO DETERMINED THAT THE MOTION CONCEPTS DID NOT PROVIDE THE REPORTED CUSHION OR THE FOOTBOX, WHICH CAUSED THE UNFORTUNATE INCIDENT. THOSE WERE THIRD PARTY ITEMS, WHICH WERE ADDED TO THE SEATING SYSTEM BY THE DEALER. IT WAS ALSO NOTED THAT THE DEALER (B)(6), DID NOT FIX THE ISSUE WHEN THE ISSUE WAS IDENTIFIED DURING THE MAINTENANCE, AND THEY DID NOT CONTACT MOTION CONCEPTS OR OUR IMPORTER FOR RESOLVING THE ISSUE. SO, 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, (B)(6) WAS NOTIFIED BY INVACARE COOPERATION, THAT ONE OF THE DEALERS IN (B)(6) INFORMED THEM OF AN INCIDENT THAT WAS RELATED TO A MOTION CONCEPTS WHEELCHAIR. THE WHEELCHAIR WAS SOLD TO (B)(6) HEALTH CARE (B)(6) BUT (B)(6) WAS MAINTAINING IT. THEY NOTIFIED THAT THE CUSHION ON THE SYSTEM SLIPPED FORWARD, AND THE END USER GOT PRESSURE SORES ON HER HIP AND BOTTOM OF HER HEEL THAT WAS IN A FOOTBOX. THE DEALER ALSO REPORTED THAT THE END-USER HAD TO CALL HER HEALTHCARE PERSON TO CHECK FOR THE PRESSURE SORES AND CONFIRMED THAT THE PRESSURE SORES WERE DEVELOPED GRADUALLY, AS THE DEALER DID NOT KNOW HOW TO FIX THE WHEELCHAIR WHEN THE ISSUE WAS DETECTED. MOTION CONCEPTS WAS NEVER NOTIFIED ABOUT THE ISSUE UNTIL THE INCIDENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2209252 POWERED WHEELCHAIR SYSTEM WHEELCHAIR ITI MOTION CONCEPTS LP 45T-12L-RESR-MAXX 00754014710065

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other