BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 4120697 · Received September 26, 2014

    Report

    Report Number
    3008262382-2014-01300
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 8, 2014
    Manufacturer
    INVACARE REHABILITATION EQUIP
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CONSUMER WAS IN THE WHEELCHAIR GOING DOWN THE RAMP AND THE CHAIR SUDDENLY STOPPED MOVING CAUSING THE USER TO FLY OUT OF HIS CHAIR. HE OK. UPDATE: CUSTOMER CALLED BACK AND WANTED WARRANTY INFORMATION. HE ALSO INDICATED THAT HIS ERROR CODE IS FLASHING WRENCH 8 OR 9 TIMES. THE SPEED INDICATOR LIGHTS CHASE LEFT TO RIGHT. (B)(4). HE ALSO STATES HE IS 90% SURE THEY NEVER REPLACED THE JOYSTICK AND TOLD US THEY CHANGED IT AND SENT BACK SOMEONE ELSES. HE BELIEVES THIS WAS IN MARCH. ORDER FOR JOYSTICK RECALL WAS (B)(4) WHICH WOULD INDICATE THE JOYSTICK WOULD BE UNDER 6 MONTH PART WARRANTY IF THAT IS THE PROBLEM. ADVISED CUSTOMER TO HAVE CHAIR DIAGNOSED BY AUTHORIZED DEALER. END USER CALLED IN 3 TIMES TODAY. FIRST SAID 7 FLASHES. THEN SAID 8 FLASHES. THEN SAID 5 FLASHES. THEN SAID 4 FLASHES. THEN SAID WE TOLD HIM THE JOYSTICK WAS THE PROBLEM SO HE HAD IT REPLACED. STATES HE WILL NOT WORK WITH A DEALER AS THEY ARE ALL RIP OFFS. END-USER STATES JUST CHANGED BATTERIES YESTERDAY. CALL DROPPED WHILE ASKING ME IF THAT COULD HAVE CAUSED THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601257 POWERED WHEELCHAIR 890.3860 ITI INVACARE REHABILITATION EQUIP M41SR20B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other