BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2870904 · Received December 12, 2012

    Report

    Report Number
    1525712-2012-02885
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    MDR DECISION DATE: (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    MDR DECISION DATE: (B)(6) - NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PER DEALER BRAKE IS DISENGAGING AND CHAIR IS GOING IN CIRCLES. THE INCIDENT WAS RE-REVIEWED AND HAS BEEN UPDATED TO A REPORTABLE MALFUNCTION. MDR FILED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other