BEUDAMED
    FDA Adverse Event Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2703329 · Received August 16, 2012

    Report

    Report Number
    1531186-2012-00724
    Date Received
    August 16, 2012
    Report Date
    September 14, 2012
    Manufacturer
    JUMAO MEDICAL EQUIPMENT
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) ISSUED MFG REPORT #1531186-2012-00724 INDICATING THE MODEL NUMBER AS SX5. THE CORRECT MODEL NUMBER IS TRSX58FB. (B)(4) NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL SX5, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 3 MONTHS OLD. THE OWNER' MANUAL PART NUMBER 1110550 REV G (FEB-11) WAS ISSUED WITH THIS DEVICE. THE OWNER' MANUAL IS ALSO FOUND ON-LINE AT INVACARE.COM. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE OWNER' 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 MALE 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. MALFUNCTION HAS NOT BEEN CONFIRMED.

    Additional Manufacturer Narrative · 1

    16AUG12 - LG - NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL SX5, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 3 MONTHS OLD. THE OWNER'S MANUAL PART NUMBER 1110550 REV G (FEB-11) 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 MALE CONSUMERS AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMERS MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN. THE CONSUMERS TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    END USER STATES "THE (B)(4) WAS DELIVERED WITH LOOSE ARMRESTS." NO INJURY ALLEGED.

    Description of Event or Problem · 1

    END USER STATES "THE SX5 WAS DELIVERED WITH LOOSE ARMRESTS." NO INJURY ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR JUMAO MEDICAL EQUIPMENT TRSX58FB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other