BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 1982547 · Received January 11, 2011

    Report

    Report Number
    1525712-2011-00005
    Event Type
    Malfunction
    Date Received
    January 11, 2011
    Report Date
    January 10, 2011
    Manufacturer
    INVACARE
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEALER CONTACTED INVACARE STATING A CONSUMER ALLEGEDLY SAW SMOKE COMING FROM HER CHAIR. THE CHAIR HAS BEEN IN SERVICE FOR 3 YRS. THE DAMAGED COMPONENT REQUESTED BY THE DEALER WAS SENT AND THE DEALER HAS YET TO RETURN THE ALLEGED DAMAGED COMPONENT. THE MFR HAS MADE REPEATED ATTEMPTS IN CONTACTING THE DEALER REGARDING THE CHAIRS REPAIR AND RETURN OF COMPONENT WITH NO RESPONSE. AS NOTED, NO INJURY WAS REPORTED NOR COULD INVACARE GET THE ALLEGEDLY DEFECTIVE PARTS BACK FOR EVAL IN ORDER TO CONFIRM A SMOKE EVENT OR DISCERN A POSSIBLE FAILURE MODE. NONETHELESS, THIS MDR IS BEING FILED IN RESPONSE TO FORM FDA (B)(4) NOTATION.

    Description of Event or Problem · 1

    THE CONSUMER ALLEGES SHE SAW SMOKE COMING FROM THE CHAIR. NO INJURY IS ALLEGED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR