BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2243357 · Received September 12, 2011

    Report

    Report Number
    1525712-2011-00502
    Event Type
    Malfunction
    Date Received
    September 12, 2011
    Report Date
    September 9, 2011
    Manufacturer
    INVACARE
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). HAS BEEN ISSUED FOR THE RETURN OF THE WHEEL CHAIR. THIS ISSUE WAS DISCOVERED DURING THE INITIAL SET-UP OF THE DEVICE. FURTHER CONFIRMATION CAME FROM THE INVACARE TERRITORY BUSINESS MANAGER UPON ARRIVAL. THE CHAIR WAS NEVER DELIVERED TO THE CUSTOMER. ELECTRONIC MALFUNCTIONS WITHIN THE CONTROLLER, INCLUDING ANY DEBRIS THAT MAY RESULT, ARE WELL CONTAINED WITHIN THE METAL ENCLOSURE OF THE DEVICE. IF THERE WAS AN ELECTRONIC COMPONENT FAILURE, A BURNING SMELL CAN OCCUR HOWEVER THIS IS NOT AN INDICATION OF SUSTAINED COMBUSTION. MALFUNCTION HAS NOT BEEN ESTABLISHED. PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION AT THIS TIME SO IT IS UNKNOWN IF A MALFUNCTION OCCURRED OR IF OTHER FACTORS SUCH AS SHIPPING MAY HAVE CAUSED OR CONTRIBUTED TO THIS INCIDENT. IF DEVICE IS RETURNED AND THE EVALUATION ESTABLISHES MALFUNCTION A FOLLOW UP MDR WILL BE COMPLETED.

    Description of Event or Problem · 1

    THE ELEVATE ACTUATOR ALLEGEDLY SMELLED HOT. THE ACTUATOR WAS REPLACED. THE TBM WENT TO LOOK AT THE CHAIR AND ALLEGES WHEN THE CHAIR ELEVATES, THE SMELL RETURNS AND GETS STRONGER. THE CHAIR WAS NEVER DELIVERED TO CONSUMER. THE CHAIR IS BEING RETURNED TO IVC. NO INJURY IS ALLEGED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other