BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2940842 · Received February 4, 2013

    Report

    Report Number
    1525712-2013-00753
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Report Date
    January 31, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DEALER STATES THE CONSUMER USES THIS CHAIR ON HIS FARM LAND AND SO THE HEADTUBE JOURNAL THAT THE FORK ASBLY SLIDES UP INTO IS RUSTED AND SEIZED UP. FORK DOES NOT TURN. LOT OF PLAY IN HEADTUBE. BEARINGS ARE RUSTED OUT TOO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47148 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET 1110695

    Patients

    Seq Age Sex Outcome Treatment
    1 Other