BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AERO T

    MDR report key: 10120224 · Received June 4, 2020

    Report

    Report Number
    3032618-2020-00004
    Event Type
    Injury
    Date Received
    June 4, 2020
    Date of Event
    May 8, 2020
    Report Date
    June 4, 2020
    Manufacturer
    TISPORT, LLC
    Product Code
    IOR
    PMA / PMN Number
    K990358
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE DHR FOR THIS CHAIR WAS REVIEWED AND THE CHAIR PASSED ALL APPLICABLE QUALITY TESTS AND CONFIGURATION REQUIREMENTS. IT MET ALL SPECIFICATIONS WHEN IT LEFT THE FACILITY. THE CLIENT GOT A NEW AERO T WHEELCHAIR (B)(6) 2020. ON (B)(6) 2020 WE DID A WARRANTY REPLACEMENT OF THE BACKREST HINGES AND THE RELEASE BAR. THIS WAS BECAUSE THE LOCKING BACKREST WAS NOT LOCKING AND KEPT POPPING FORWARD. THE DEALER WAS NOT ABLE TO FIX THE PROBLEM. LIMITED INFORMATION WAS PROVIDED BY THE CUSTOMER REGARDING THE EXACT NATURE OF THE ALLEGED INCIDENT. THE CUSTOMER CLAIMS THAT WHILE PERFORMING PRESSURE RELIEF, THE CHAIR BACK "POPPED" FORWARD, CAUSING THEM TO FALL FORWARD OUT OF THE CHAIR. ACCORDING TO THE INFORMATION PROVIDED, THIS INCIDENT RESULTED IN A TRIP TO THE EMERGENCY ROOM. HOWEVER, NO FURTHER INFORMATION REGARDING THE INJURIES SUSTAINED WAS PROVIDED. WE HAVE REQUESTED THAT THE CHAIR BE RETURNED BUT HAVE NOT YET RECEIVED IT. A FOLLOW UP MEDWATCH FORM 3500A WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION IS PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT WHILE PERFORMING PRESSURE RELIEF, THE CHAIR BACK DID NOT STAY LOCKED IN THE UPRIGHT POSITION AND CAUSED THE USER TO FALL FORWARD, SUSTAINING AN UNKNOWN INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584228 AERO T WHEELCHAIR IOR TISPORT, LLC AERO T

    Patients

    Seq Age Sex Outcome Treatment
    1 Other