BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2662903 · Received July 20, 2012

    Report

    Report Number
    1525712-2012-01017
    Event Type
    Malfunction
    Date Received
    July 20, 2012
    Report Date
    July 19, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO RMA HAS BEEN INITIATED FOR THIS ISSUE. HOWEVER, A QUOTE FOR THE RMA HAS BEEN PROVIDED (B)(4). MODEL TDXSP-MCG, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 1 MONTH OLD. THE OWNER'S MANUAL PART NUMBER 1143190 REV K (MAR-11) WAS ISSUED WITH THIS DEVICE. THE OWNER'S MANUAL IS ALSO FOUND ON-LINE AT INVACARE.COM. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE OWNER'S MANUAL. DOCUMENTATION PROVIDES WARNINGS, CAUTIONS, AND INSTRUCTIONS FOR SAFELY USING THE DEVICE. IF THE CONSUMER DOES NOT UNDERSTAND THE WRITTEN WARNINGS, CAUTIONS OR INSTRUCTIONS THEN THEY SHOULD CONTACT INVACARE. THE CONSUMER'S AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMER'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMER'S TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. THE DEALER CALLED STATING THAT WHEN THEY RECEIVED THE TDXSP-MCG POWER CHAIR THE LEFT SIDE ELEVATING LEG REST (ELR) WAS ALLEGEDLY STUCK. THE DEALER CALLED INVACARE AND WITH TROUBLESHOOTING WITH A TECHNICIAN WAS ABLE TO GET THE LEFT ELR FUNCTIONING. SINCE THAT TIME, THE LEFT ELR IS NOT FUNCTIONING. THE DEALER WILL SWITCH OUT THE ACTUATOR. THIS IS AN OUT OF BOX FAILURE FOR THE ELR AT THE DEALERSHIP. NO INJURY ALLEGED.

    Description of Event or Problem · 1

    DEALER CALLED STATING THAT WHEN THEY RECEIVED THE POWER CHAIR THE LEFT ELEVATING LEG REST (ELR) WAS ALLEGEDLY STUCK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other