BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2000629 · Received February 2, 2011

    Report

    Report Number
    1525712-2011-00038
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Report Date
    February 2, 2011
    Manufacturer
    INVACARE
    Product Code
    ITI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER SPOKE WITH THE DEALER THAT AS THE CHAIR. INFO PROVIDED ALLEGES THE CHAIR SMOKED AND STOPPED WORKING. THE CHAIR APPEARS TO HAVE HAD BEEN SERVICED SEVERAL TIMES PRIOR TO THE ALLEGED INCIDENT. MALFUNCTION IS NOT CONFIRMED. MANUFACTURER IS ATTEMPTING TO OBTAIN PRODUCT FOR INSPECTION. PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION AT THIS TIME SO IT IS UNK IF A MALFUNCTION OCCURRED OR IF OTHER FACTORS SUCH AS MISUSE, ABUSE OR A SERVICE ERROR THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS ALLEGED INCIDENT. MANUFACTURER IS ATTEMPTING TO OBTAIN PRODUCT FOR INSPECTION.

    Description of Event or Problem · 1

    THE CHAIR ALLEGEDLY SMOKED AND STOPPED WORKING. 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