BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVACARE POWER WHEELCHAIR

    MDR report key: 1031250 · Received April 18, 2008

    Report

    Report Number
    1525712-2008-00035
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    March 21, 2008
    Report Date
    April 14, 2008
    Manufacturer
    INVACARE CORPORATION - MANUFACTURING FACILITY
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER CONTACTED THE DEALER. DEALER REPORTS HE HAD PICKED UP THE CHAIR AND RAN THE CHAIR FOR OVER AN HOUR. NO FUNCTIONAL PERFORMANCE WAS FOUND TO BE WRONG. THE DEALER DID NOTE THAT THE CHAIR IS ALLEGEDLY PROGRAMMED AGGRESSIVELY WITH A HIGH TORQUE. THE DEALER BELIEVES THIS IS WHAT CAUSED THE ALLEGED INCIDENT. INFORMATION INDICATES A POTENTIAL USER ERROR AND/OR CHAIR MAY NOT BE APPROPRIATE FOR USER.

    Description of Event or Problem · 1

    THE CONSUMER CAME UP TO A SLIGHT SLOPE ON THE SIDEWALK WHEN THE BRAKE ALLEGEDLY WENT ON AND THE CHAIR DROVE LEFT. THE LEFT MOTOR ALLEGEDLY SEIZED UP CAUSING THE CHAIR TO FALL ON ITS RIGHT SIDE. THE BUCKLE ALLEGED FAILED CAUSING THE CONSUMER TO FALL OUT OF THE CHAIR AND GET A CONCUSSION AND TEAR HER RIGHT ROTATOR CUFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVACARE POWER WHEELCHAIR 890.3860 ITI INVACARE CORPORATION - MANUFACTURING FACILITY TDXSP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention