BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2955882 · Received February 11, 2013

    Report

    Report Number
    1525712-2013-00994
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Report Date
    February 11, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    MDR DECISION DATE: (B)(4). NO RMA HAS BEEN INITIATED FOR THIS ISSUE. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    DEALER STATES CHAIR TILT MOVES ON ITS OWN. DEALER WAS NOT WITH THE CHAIR TO TROUBLESHOOT. DEALER STATES HE HAS TRIED A NEW 4WAY TOGGLE SWITCH AND IT STILL DOES IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58488 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET TDXSPREE-CG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other