BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2843309 · Received November 22, 2012

    Report

    Report Number
    1525712-2012-02329
    Event Type
    Malfunction
    Date Received
    November 22, 2012
    Report Date
    November 22, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) MODEL M91-TS SERIAL NUMBER/DATE (B)(4) IS APPROXIMATELY 3 YEARS, I MONTH OLD. THE OWNER'S MANUAL PART NUMBER 1141450, REV.E(OCT-08), 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. 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 MALFUNCTION HAS NOT BEEN CONFIRMED

    Description of Event or Problem · 1

    COMPANY REPRESENTATIVE HAS REPORTED AN EVENT OF INTERMITTENT DLO (DRIVE LOCKOUT) CHAIR MOVES ON ITS OWN INTERMITTENTLY. HE IDENTIFIED THE PART NEEDS REPLACEMENT. THERE WAS NO INJURY OR ILL EFFECT TO THE END USER. FURTHER INFORMATION WILL BE PROVIDED IN A FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET M91-TS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other