BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TDXSP WET BLACK EURO NARROW BASE W/ 23-1 SSD GEAR BOX

    MDR report key: 4567250 · Received March 4, 2015

    Report

    Report Number
    1525712-2015-01572
    Event Type
    Malfunction
    Date Received
    March 4, 2015
    Report Date
    February 24, 2015
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    CALL CAME FROM (B)(4) IN TECHNICAL SERVICES, THE DEALER STATES HE REPLACED THE JOYSTICK ABOUT A MONTH AGO DUE TO IT WAS RACING. HE REPLACED THAT JOYSTICK AND THE NEW UNIT IS RACING. HE IS GOING TO CALL BACK WITH REFERENCE NUMBERS REGARDING THE ISSUES . NO OTHER INFORMATION AVAILABLE. THE RECALL HAS NOT BEEN DONE ON THE CHAIR . (B)(4) MW6285 DLR RETURNED NEW JS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149975 TDXSP WET BLACK EURO NARROW BASE W/ 23-1 SSD GEAR BOX WHEELCHAIR, POWERED ITI INVACARE TAYLOR STREET TDXSP-CG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other