BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3133299 · Received May 29, 2013

    Report

    Report Number
    1525712-2013-04214
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    January 29, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    INVACARE AWARENESS DATE 01/29/2013. COMPLAINT WAS NOT GIVEN TO REGULATORY AFFAIRS FOR PROCESSING UNTIL 05/23/2013. MALFUNCTION ALLEGED. NO SERIOUS INJURY ALLEGED. PER DEALER, THE CHAIR IS STALLING OUT.

    Description of Event or Problem · 1

    PROVIDER STATES CHAIR STALLS OUT (ERROR CODE), SHOWS RIGHT MOTOR FAULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236781 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSP-MCG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other