BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2GX

    MDR report key: 8741915 · Received June 27, 2019

    Report

    Report Number
    3032618-2019-00006
    Event Type
    Injury
    Date Received
    June 27, 2019
    Date of Event
    May 24, 2019
    Report Date
    June 27, 2019
    Manufacturer
    TISPORT, LLC
    Product Code
    IOR
    PMA / PMN Number
    K072311
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    WE REVIEWED THE DHR FOR THIS CHAIR, AND IT PASSED ALL APPLICABLE QUALITY TESTS AND CONFIGURATION REQUIREMENTS, AND MET ALL SPECIFICATIONS AS ORDERED WHEN IT LEFT THE FACILITY. THE REVIEW OF THE DHR SHOWS THAT A PARTS ORDER MADE A MONTH PRIOR TO THE EVENT WAS SENT OUT TO REPLACE ARMREST RECEIVER AND SADDLE, WHICH ARE RESPONSIBLE FOR HOLDING THE ARMREST IN PLACE. DUE TO THE TIMING OF THIS PARTS ORDER AND THE OCCURENCE OF THIS EVENT, IT IS LIKELY THE ARMREST RECEIVER AND SADDLE WERE NOT INSTALLED CORRECTLY. WE HAVE SENT REPLACEMENT PARTS AND PROVIDED INSTRUCTIONS TO CORRECTLY INSTALL THE REPLACEMENTS. THE OWNERS MANUAL PRESCRIBES INITIAL AND WEEKLY INSPECTION OF ALL ARMREST HARDWARE TO ENSURE IT IS SECURELY ATTACHED. IN ADDITION, THE OWNERS MANUAL DOES NOT RECOMMEND TRANSFERRING USING THE SWING AWAY ARMREST ASSEMBLIES, AND RECOMMENDS TO "ALWAYS REMOVE THE WHEELCHAIR ARMRESTS, OR SWING THEM OUT OF THE WAY, SO THEY DO NOT IMPEDE YOUR MOVEMENT DURING THE TRANSFER."

    Description of Event or Problem · 1

    CUSTOMER CLAIMS THAT THE ARMRESTS WOULD NOT STAY IN PLACE, AND WHEN SHE WAS TRANSFERRING FROM HER CHAIR TO A BED, SHE FELL OUT. THE FALL RESULTED IN A BROKEN LEG AND A BLACK EYE. SHE RECEIVED TREATMENT AT A HOSPITAL WHERE SHE IS RECOVERING WITH NO REPORTED COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534854 2GX WHEELCHAIR IOR TISPORT, LLC 2GX

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization