BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TILITE 2GX SERIES 2

    MDR report key: 5870493 · Received August 11, 2016

    Report

    Report Number
    3032618-2016-00005
    Event Type
    Malfunction
    Date Received
    August 11, 2016
    Date of Event
    July 7, 2016
    Report Date
    August 5, 2016
    Manufacturer
    TISPORT, LLC
    Product Code
    IOR
    PMA / PMN Number
    K072311
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DHR FOR THIS DEVICE WAS CONDUCTED, THE CHAIR WAS BUILT ACCORDING TO SPECIFICATION. ALTHOUGH THE CHAIR OR PARTS WERE NOT PHYSICALLY AVAILABLE FOR EVALUATION, PHOTOS WERE PROVIDED FOR INVESTIGATIONAL PURPOSES. EVALUATION OF THE PHOTOS REVEALED THAT A FRACTURE IN THE COMPONENT WAS A RESULT OF STRESS. IN THE HISTORY OF TILITE, THIS IS THE FIRST OF THIS COMPONENT THAT HAS DEVELOPED A FRACTURE THAT HAS BEEN REPORTED. WE ARE TRYING TO GET THE PART BACK IN ORDER TO REVIEW THE CRACK AND EFFORTS ARE BEING MADE TO TRY AND REPLICATE THIS FRACTURE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP MDR WILL BE FILED.

    Description of Event or Problem · 1

    THE AXLE CLAMP CRACKED, RELEASING THE CAMBER PLUG/AXLE SLEEVE AND THE CLIENT FELL OUT OF CHAIR AND LANDED ON HIS AMPUTATED STUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520572 TILITE 2GX SERIES 2 WHEELCHAIR MECHANICAL IOR TISPORT, LLC 2GX SERIES 2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other