BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2940263 · Received February 2, 2013

    Report

    Report Number
    1525712-2013-00763
    Event Type
    Malfunction
    Date Received
    February 2, 2013
    Report Date
    February 1, 2013
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    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

    CONSUMER ALLEGES THAT THE UNIT RESISTS WHEN HE IS TRYING TO TAKE A TURN. CONSUMER ALSO ALLEGES THAT THE UNIT WILL NOT REACH MAXIMUM SPEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45571 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET P9000XDT1816

    Patients

    Seq Age Sex Outcome Treatment
    1 Other