BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 1821160 · Received August 26, 2010

    Report

    Report Number
    1525712-2010-00124
    Event Type
    Injury
    Date Received
    August 26, 2010
    Date of Event
    July 1, 2010
    Report Date
    August 25, 2010
    Manufacturer
    INVACARE
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER RECEIVED COMPLAINT A USER FELL OUT OFF DUE TO A FRAME BREAKAGE. ON (B)(6) 2010, MANUFACTURER SPOKE WITH CONSUMER WHO ALLEGED THEY SOUGHT MEDICAL TREATMENT FROM THEIR HOME CARE NURSE REGARDING AN EXTRA WOUND. THE CHAIR WAS RECEIVED AND INSPECTED. THERE WERE MARKS ON THE FRAME OF THE CHAIR INDICATING THE CHAIR WAS SECURED AT SOME POINT. ADDITIONAL HARDWARE WAS OBSERVED ON THE FRONT OF THE CHAIR FURTHER SUGGESTING A TIE DOWN FUNCTION. IN CONVERSING WITH THE USER HE HAS ADVISED HE IS USING A PUBLIC TRANSPORTATION VEHICLE THAT SECURES HIS CHAIR WHILE HE IS SEATED. AS OF THIS DATE, THE DEPT OF TRANSPORTATION HAS NOT APPROVED ANY TIE-DOWN SYSTEMS FOR TRANSPORTATION OF A USER WHILE IN A WHEELCHAIR, IN A MOVING VEHICLE OF ANY TYPE. IT IS INVACARE'S POSITION THAT USERS OF WHEELCHAIRS SHOULD BE TRANSFERRED INTO APPROPRIATE SEATING IN VEHICLES FOR TRANSPORTATION AND USE BE MADE OF THE RESTRAINTS MADE AVAILABLE BY THE AUTO INDUSTRY. INVACARE CANNOT AND DOES NOT RECOMMEND ANY WHEELCHAIR TRANSPORTATION SYSTEMS. THIS INCIDENT CLEARLY IS A RESULT OF IMPROPER USE. MDR FILED BASED ON ALLEGED UNCONFIRMED MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    THE CONSUMER ALLEGEDLY HEARD A LOUD BANG AND WHEN HE ATTEMPTED TO GET OUT OF THE CHAIR, THE WELDS ALLEGEDLY SNAPPED OFF ON THE TILT FRAME, CAUSING HIM TO FALL AND SCRAPE HIS LEGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE 3GAR POWER CHAIR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention