BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 4131491 · Received October 1, 2014

    Report

    Report Number
    1525712-2014-06528
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Report Date
    September 11, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PROVIDER STATES HE SPOKE TO AL J IN TECH SERVICES X7973 TO ADVISE THAT THE CONSUMER REPORTS WHEN HE IS GOING UP THE RAMP THE CHAIR STOPS AND THE SERVICE LIGHT FLASHES. PROVIDER COULD NOT REPLICATE THE ISSUE WHEN EVALUATING THE CHAIR. PROVIDER HUNG UP BEFORE ANY ADDITIONAL INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611854 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET M51PR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other