BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2834350 · Received November 15, 2012

    Report

    Report Number
    3004493922-2012-00483
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Report Date
    November 15, 2012
    Manufacturer
    INVACARE SUZHOU
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), NO RMA HAS NOT BEEN INITIATED FOR THIS ISSUE. MODEL PRONTO M41 SERIAL NUMBER/DATE CODE (B)(4) APPROXIMATELY 1 MONTH OLD. THE OWNER'S MANUAL PART NUMBER 1143206, REV.G(FEB-09) 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 MALFUNCTION HAS NOT BEEN CONFIRMED. IF ANY FURTHER INFORMATION IS RECEIVED ON THIS INCIDENT, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    DEALER STATED MOTOR ISSUE. THERE IS NO FURTHER INFORMATION. NO HARM OR INJURY HAS BEEN REPORTED ON THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE SUZHOU PRONTO M41

    Patients

    Seq Age Sex Outcome Treatment
    1 Other