BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TDXSP ELECTRIC RED EURO WIDE BASE W/ 23-1 SSD GEAR BOX

    MDR report key: 4332621 · Received December 16, 2014

    Report

    Report Number
    1525712-2014-07918
    Event Type
    Malfunction
    Date Received
    December 16, 2014
    Report Date
    October 28, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER DEALER, ON THE LNX ACTUATOR, THE ACTUAL ACTUATOR CRACKED AND THE PISTON FELL OUT, DEALER IS STATING THAT IT LOOKS LIKE PHYSICAL DAMAGE, LOOKS AS IF THE LEGS WERE EXTENDED AND RAN INTO SOMETHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822192 TDXSP ELECTRIC RED EURO WIDE BASE W/ 23-1 SSD GEAR BOX WHEELCHAIR, POWERED ITI INVACARE TAYLOR STREET TDXSP-CG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other