BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2760103 · Received September 26, 2012

    Report

    Report Number
    3004493922-2012-00367
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Report Date
    September 25, 2012
    Manufacturer
    INVACARE SUZHOU
    Product Code
    ITI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL M41SRB, SERIAL NUMBER/DATE (B)(4) IS APPROXIMATELY 5 YEARS AND 1 MONTH OLD. THE OWNER'S MANUAL PART NUMBER 1143206, 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. A CALL WAS PLACED TO THE REPORTER OF THE EVENT. NO FURTHER INFORMATION RECEIVED ON AGE, HEIGHT AND WEIGHT, MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN. THE CONSUMER'S TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. THE MALFUNCTION HAS NOT BEEN CONFIRMED. THE REPORTER STATED THAT THERE ARE TIMES WHEN THE DEVICE MOVES FROM SIDE TO SIDE WHILE GOING DOWN A RAMP AND HAS BUMPED INTO CABINETS AND DOORWAYS. SHE STATED THERE IS A PIN UNDER THE CENTER OF THE CHAIR THAT IS BROKEN AND THE DEVICE IS BEING EVALUATED BY THE DEALER TO REPAIR THE PIN.

    Description of Event or Problem · 1

    END USER STATES: SHE HAS HAD PROBLEMS SINCE SHE PURCHASED THE PRONTO M41. CUSTOMER SAYS THE CENTER BOLT, WHICH KEEPS THE CHAIR / SEAT STABLE HAS CONSTANTLY GIVEN HER PROBLEMS, IT IS WOBBLY. CUSTOMER ALLEGES NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERED WHEELCHAIR 890.3860 ITI INVACARE SUZHOU M41SRB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other