BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2052481 · Received March 15, 2011

    Report

    Report Number
    1525712-2011-00093
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Date of Event
    February 1, 2009
    Report Date
    March 11, 2011
    Manufacturer
    INVACARE
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONSUMER OBSERVED SMOKE COMING FROM THE (B)(4) BOX. THE (B)(4) BOX WAS RECEIVED AND INSPECTED. NO EXTERNAL HEAT DAMAGE WAS OBSERVED ON THE BOX OR ITS WIRES. THE METAL BOX WAS DISASSEMBLED AND INTERNAL HEAT DAMAGE TO THE PC BOARD WAS OBSERVED. AS WITH ANY ELECTRONIC DEVICE, ELECTRONIC COMPONENT FAILURES OCCUR AS ONE DID IN THIS CONTROL BOX. HOWEVER FAILURES OF THIS TYPE ARE WELL CONTAINED INTERNALLY WITHIN THE METAL HOUSING OF THE CONTROL BOX. DURING THE EVENT THE CONTROL BOX LIKELY EMITTED SMOKE FOR A BRIEF TIME, HOWEVER NO FIRE OCCURRED AND NO HEAT DAMAGE WAS EXTERNAL TO THE COMPONENT. THE DEALER HAS REPLACED THE BOX, AND THE CHAIR REMAINS IN SERVICE.

    Description of Event or Problem · 1

    THE CONSUMER'S HUSBAND ALLEGES HE SAW SMOKE COMING FROM THE (B)(4) BOX. NO INJURY IS ALLEGED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR