BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 1944417 · Received December 16, 2010

    Report

    Report Number
    1525712-2010-00175
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    November 8, 2010
    Report Date
    December 15, 2010
    Manufacturer
    INVACARE
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE SITTING IN THEIR CHAIR, THE CONSUMER ALLEGES THE CHAIR HAD MOVED AND IMPACTED THE WALL AND DRESSER. THIS RESULTED IN AN ALLEGED, UNCONFIRMED INJURY. NATURE OF COMPLAINT SUGGESTS UNINTENDED ENGAGEMENT OF THE JOYSTICK WHILE THE DEVICE WAS POWERED ON. MDR FILED AS A CONSERVATIVE MEASURE.

    Additional Manufacturer Narrative · 1

    INITIAL (B)(4) ISSUED MFG REPORT #1525712-2010-00175. END-USER ALLEGES THAT SHE WAS SITTING WATCHING TV AND CHAIR TOOK OFF GOING FORWARD, RUNNING INTO DRESSER AND SUSTAINED A BROKEN SHOULDER. THE PRODUCT HAD BEEN REPLACED AND THE DEVICE IN QUESTION WAS RETURNED FOR EVALUATION. VISUAL: THE PHYSICAL DAMAGE TO THE MICROCONTROLLER IS APPARENT. FUNCTIONAL: THE MICROCONTROLLER WAS OPENED ON THE PCB HAD BEEN PHYSICALLY DAMAGED BY OTHER WIRING COMPONENTS PUSHING AGAINST IT INSIDE THE ASSEMBLY. THIS CAUSED INTERMITTENT OPERATION WITH MOVEMENT OF THE CABLE. DURING FUNCTIONAL BENCH TESTING, THE JOYSTICK CAUSED THE MOTORS TO STOP RUNNING WHEN THE JOYSTICK CABLE WAS FLEXED. WHEN THE JOYSTICK WAS DISENGAGED, THE MOTORS CONTINUED TO DRIVE. THE CONTROL CABLE HAD TO BE PHYSICALLY REMOVED FOR THE MOTORS TO STOP MOVEMENT. THE MALFUNCTION WAS VERIFIED IN BENCH TESTING. WHILE SITTING IN THEIR CHAIR, THE CONSUMER ALLEGES THE CHAIR HAD MOVED AND IMPACTED THE WALL AND DRESSER. THIS RESULTED IN AN ALLEGED, UNCONFIRMED INJURY. NATURE OF COMPLAINT SUGGESTS UNINTENDED ENGAGEMENT OF THE JOYSTICK WHILE THE DEVICE WAS POWERED ON. MDR FILED AS A CONSERVATIVE MEASURE.

    Description of Event or Problem · 1

    THE CONSUMER WAS SITTING IN THE CHAIR WATCHING TELEVISION, WHEN THE CHAIR ALLEGEDLY TOOK OFF, RUNNING HER INTO THE WALL AND A DRESSER. THE CONSUMER ALLEGEDLY SUSTAINED A BROKEN RIGHT SHOULDER.

    Description of Event or Problem · 1

    THE CONSUMER WAS SITTING IN THE CHAIR WATCHING TELEVISION, WHEN THE CHAIR ALLEGEDLY TOOK OFF, RUNNING HER INTO THE WALL AND A DRESSER. THE CONSUMER ALLEGEDLY SUSTAINED A BROKEN RIGHT SHOULDER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention