BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2873181 · Received December 13, 2012

    Report

    Report Number
    3004493922-2012-00692
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Report Date
    December 13, 2012
    Manufacturer
    INVACARE SUZHOU
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    (B)(4) - NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. DEALER STATES LEFT MOTOR SEIZED UP. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE SUZHOU M41SR16B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other