BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2950698 · Received February 8, 2013

    Report

    Report Number
    3004493922-2013-00266
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Report Date
    February 7, 2013
    Manufacturer
    INVACARE SUZHOU
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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

    DEALER STATES CHAIR HAS INTERMITTENT OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54229 POWERED WHEELCHAIR 890.3860 ITI INVACARE SUZHOU PRONTO M41

    Patients

    Seq Age Sex Outcome Treatment
    1 77 Other