BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2820020 · Received November 5, 2012

    Report

    Report Number
    1525712-2012-02082
    Event Type
    Malfunction
    Date Received
    November 5, 2012
    Report Date
    November 3, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. MODEL CT7A SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 5 MONTHS OLD. THE OWNER'S MANUAL PART NUMBER 1110558 WAS ISSUED WITH THIS DEVICE. THE OWNER'S MANUAL IS ALSO FOUND ON-LINE AT INVACARE.COM. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE OWNER'S MANUAL. DOCUMENTATION PROVIDES WARNINGS, CAUTIONS, AND INSTRUCTIONS FOR SAFELY USING THE DEVICE. IF THE CONSUMER DOES NOT UNDERSTAND THE WRITTEN WARNINGS, CAUTIONS OR INSTRUCTIONS THEN THEY SHOULD CONTACT INVACARE. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    A REPORT HAS BEEN RECEIVED ON THIS MANUAL WHEELCHAIR WHERE THE FORK ON THE FRONT END CASTER HAS COME CLOSE LOOSE FROM THE CASTER JOURNAL HOWEVER REMAINS ATTACHED BUT RATTLES ON DIFFERENT SURFACES. ALSO ON THE FRAME ON SOME AREAS WERE CIRCULAR AND ARE CONSISTENT WITH SOME TYPE OF BUBBLING . REPORTEDLY, THE CHAIR OVERALL LOOKS GOOD AND THE USER IS GENTLE USER WHO TAKES CARE OF HER CHAIR. NO INJURY FROM THIS INCIDENT. DEALER TO REPLACE BOTH AFFECTED PARTS ON THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVACARE TAYLOR STREET CT7A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other