BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 3020214 · Received March 25, 2013

    Report

    Report Number
    3004493922-2013-00666
    Event Type
    Malfunction
    Date Received
    March 25, 2013
    Report Date
    February 26, 2013
    Manufacturer
    INVACARE SUZHOU
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    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 STATED THE UNIT SHUT DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122026 POWERED WHEELCHAIR 890.3860 ITI INVACARE SUZHOU M41SRB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other