BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2767690 · Received October 1, 2012

    Report

    Report Number
    1525712-2012-01678
    Event Type
    Malfunction
    Date Received
    October 1, 2012
    Report Date
    October 1, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) MODEL PRONTO M 94, SERIAL NUMBER/DATE CODE IS UNKNOWN AD THE AGE OF THE DEVICE IS UNKNOWN. THE OWNER'S MANUAL PART NUMBER 1122145, REV.I(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. IF THE CONSUMER DOES NOT UNDERSTAND THE WRITTEN WARNINGS, CAUTIONS OR INSTRUCTIONS THEN THEY SHOULD CONTACT INVACARE. THE CONSUMER WAS CONTACTED FOR ADDITIONAL INFORMATION. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    THE REPORTER OF THIS EVENT VERBALLY REPORTED THE CASTERS BROKE. NO INJURY REPORTED AND REPORTEDLY THE DEVICE HAS BEEN REPAIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET PRONTO M94

    Patients

    Seq Age Sex Outcome Treatment
    1 44 Other