BEUDAMED
    FDA Adverse Event Death Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 1328620 · Received February 4, 2009

    Report

    Report Number
    1525712-2009-00035
    Event Type
    Death
    Date Received
    February 4, 2009
    Date of Event
    April 8, 2007
    Report Date
    February 25, 2009
    Manufacturer
    INVACARE
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER SPOKE WITH CONSUMER AT LENGTH REGARDING ALLEGED INCIDENT. USER ALLEGES HER NEPHEWS HAD BEEN TOLD TO LEAVE THE CHAIR ALONE, AND SHE ALLEGES SHE LOCKED IT AWAY. SOMEHOW HER NEPHEWS GOT THE CHAIR OUT AGAIN. TURNED THE CHAIR ON, AND ACCIDENTLY RAN OVER HER 2 YEAR OLD CHILD. MDR FILED BASED ON ALLEGED DEATH. INFORMATION REMAINS UNCONFIRMED, AND INCIDENT REPORTEDLY HAS HAPPENED IN 2007.

    Description of Event or Problem · 1

    THE CONSUMER STATES WHILE VISITING HER GRANDMOTHER, SHE LEFT HER POWER CHAIR OUTSIDE. HER 3 AND 5 YEAR OLD NEPHEWS ALLEGEDLY PUT THE FREE WHEEL HUBS BACK INTO THE DRIVE MODE, TURNED THE WHEELCHAIR ON AND STARTED TO DRIVE THE WHEELCHAIR. THE BOYS ALLEGEDLY RAN THE CONSUMER'S DAUGHTER OVER WITH THE FRONT CASTER. THE CONSUMER'S DAUGHTER SUFFERED FATAL INJURIES. THE CAUSE OF DEATH LISTED ON THE DEATH CERTIFICATE IS ASPHYXIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE UNCONFIRMED 3DT

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Death