BEUDAMED
    FDA Adverse Event Death Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 1689101 · Received May 11, 2010

    Report

    Report Number
    1525712-2010-00062
    Event Type
    Death
    Date Received
    May 11, 2010
    Date of Event
    November 11, 2009
    Report Date
    May 11, 2010
    Manufacturer
    INVACARE
    Product Code
    ITI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. COMPLAINT AS RECEIVED SUGGESTS THAT THE USER AS LEANING EXCESSIVELY AND MAY NOT HAVE BEEN USING THE SEAT POSITIONING STRAP AS DISCUSSED WITHIN THE USER GUIDE THAT SHIPS WITH THE PRODUCT. IN ADDITION, EXCESSIVELY LEANING FORWARD IN ANY WHEELCHAIR CAN RESULT IN FALLS OF THIS TYPE. PROPER USE OF THE PRODUCT IS COVERED WITHIN THE USER GUIDE. PRODUCT MALFUNCTION HAS NOT BEEN CONFIRMED. CAUSE OF DEATH WAS NOT DIRECTLY CAUSED BY THE USE OF THE DEVICE.

    Description of Event or Problem · 1

    THE CONSUMER WAS IN THE CHAIR AND STARTED CHOKING. THE CONSUMER'S DAUGHTER LEANED THE CONSUMER FORWARD AT THE WAIST TO DISLODGE THE FOOD BY PATTING HER BACK. WHILE THE CONSUMER WAS LEANING FORWARD THE CHAIR AND THE CONSUMER FELL FROM THE CHAIR. THIS ALLEGEDLY RESULTED IN A BROKEN FEMUR. WHILE IN THE EMERGENCY ROOM, THE CONSUMER HAD A REACTION TO THE PAIN MEDICATION, WHICH ALLEGEDLY RESULTED IN THE CONSUMER'S DEATH THREE DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE TDXSP

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| R