BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2874805 · Received December 16, 2012

    Report

    Report Number
    1525712-2012-03080
    Event Type
    Malfunction
    Date Received
    December 16, 2012
    Report Date
    November 16, 2012
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT # 1525712-2012-03080. DEALER STATED THAT WHEN HE PICKED UP THE WHEELCHAIR, HE NOTICED PAINT AND SCRAPES ON THE FRAME, PUSH RIMS AND WHEELS. HE STATED THAT THE DAMAGE WAS DUE TO END USER TECHNIQUE, NOT A MALFUNCTION. THIS IS NOT A REPORTABLE EVENT TO THE FDA. THE INITIAL SUBMISSION INDICTED THE MODEL AS M91 AND THE SERIAL # AS (B)(4). THE CORRECT MODEL AND SERIAL # ARE SOLARA3G AND (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) - NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL M91, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY ONE YEAR 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. IF THE CONSUMER DOES NOT UNDERSTAND THE WRITTEN WARNINGS, CAUTIONS OR INSTRUCTIONS THEN THEY SHOULD CONTACT INVACARE. THE CONSUMER IS A (B)(6). THE CONSUMER'S MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMER'S TECHNIQUE WHILE USING THE DEVICE AND THE MAINTENANCE HISTORY OF THE DEVICE ARE UNKNOWN. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    (B)(4) - THE DEALER REPORTED THAT THE M91 M91 POWER WHEELCHAIR ONE OF THE REAR WHEEL RIMS WERE CRACKED. THERE WAS NO PATIENT INJURY REPORTED.

    Description of Event or Problem · 1

    DEALER REPORTED THAT A CAREGIVER STATED THAT ONE OF THE REAR WHEEL RIMS ON A SOLARA3G TILT IN SPACE WHEELCHAIR IS CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE TAYLOR STREET SLOLARA3G

    Patients

    Seq Age Sex Outcome Treatment
    1 Other