BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 4783845 · Received May 20, 2015

    Report

    Report Number
    1525712-2015-02953
    Event Type
    Malfunction
    Date Received
    May 20, 2015
    Date of Event
    April 27, 2015
    Report Date
    April 28, 2015
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    HB-(B)(4) 2015. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A SUPPLEMENTAL RECORD WILL BE FILED.

    Description of Event or Problem · 1

    PROVIDER STATES THE TILT ACTUATOR SNAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329077 TDXSP ELECTRIC RED EURO WIDE BASE W/ 23-1 SSD GEAR BOX WHEELCHAIR, POWERED ITI INVACARE TAYLOR STREET TDX3-PS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other