BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AERO T

    MDR report key: 10203604 · Received June 26, 2020

    Report

    Report Number
    3032618-2020-00005
    Event Type
    Injury
    Date Received
    June 26, 2020
    Date of Event
    May 28, 2020
    Report Date
    June 26, 2020
    Manufacturer
    TISPORT, LLC
    Product Code
    IOR
    PMA / PMN Number
    K990358
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE DEALER, THEY PUT NEW BACKREST HINGES ON A CUSTOMER'S CHAIR BUT HAD DIFFICULTY DURING THE INSTALLATION, AS WELL AS PROBLEMS ADJUSTING THEM APPROPRIATELY. SUBSEQUENTLY, THE CUSTOMER CLAIMS THAT WHILE TRANSFERRING INTO THEIR CHAIR THE BACKREST RELEASED FROM ITS LOCKED, UPRIGHT POSITION AND CAUSED THEM TO FALL FROM THE CHAIR AND SUSTAIN A HEAD INJURY. THE DHR FOR THE CHAIR WAS REVIEWED AND THE CHAIR PASSED ALL APPLICABLE QUALITY TESTS AND CONFIGURATION REQUIREMENTS. IT MET ALL SPECIFICATIONS WHEN IT LEFT THE FACILITY. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. WITH THE INFORMATION AVAILABLE THE MANUFACTURER CONCLUDES THAT THE CAUSE OF THIS FAILURE WAS IMPROPER INSTALLATION OF THE BACKREST HINGES. A FOLLOW UP MEDWATCH FORM 3500A WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION IS PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER CLAIMS THAT WHILE ATTEMPTING TO GET INTO THEIR CHAIR THE BACKREST RELEASED FROM ITS LOCKED POSITION AND CAUSED THEM TO FALL AND HIT THEIR HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665038 AERO T WHEELCHAIR IOR TISPORT, LLC AERO T

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization