BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2587772 · Received May 24, 2012

    Report

    Report Number
    9616091-2012-00109
    Event Type
    Malfunction
    Date Received
    May 24, 2012
    Report Date
    June 7, 2012
    Manufacturer
    JUMAO MEDICAL EQUIPMENT
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - REVIEWED AS PART OF CAPA (B)(4). "CERB DID NOT REVIEW ALL NO MDR QUERY RESULTS". THIS COMPLAINT WILL BE FILED ON AS A RESULT OF THE RETROSPECTIVE REVIEW. NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL TRSX5, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 5 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 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.

    Additional Manufacturer Narrative · 1

    (B)(4). REPORT #9616091-2012-00109. THIS IS A FOREIGN MANUFACTURER. ALSO, A RMA #(B)(4) WAS ISSUED FOR THE RETURN OF THE DAMAGED PARTS FOR AN INSPECTION AND EVALUATION. (B)(4) - REVIEWED AS PART OF CAPA (B)(4) CERB DID NOT REVIEW ALL NO MDR QUERY RESULTS. THIS COMPLAINT WILL BE FILED ON AS A RESULT OF THE RETROSPECTIVE REVIEW. NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL TRSX5, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 5 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 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.

    Description of Event or Problem · 1

    CUSTOMER ALLEGED SPACER ON FLIP BACK ARM CRACKED. REPLACEMENT # (B)(4). NO INJURY ALLEGED.

    Description of Event or Problem · 1

    CUSTOMER ALLEGED SPACER ON FLIP BACK ARM CRACKED. REPLACEMENT #(B)(4). NO INJURY ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR JUMAO MEDICAL EQUIPMENT TRSX5

    Patients

    Seq Age Sex Outcome Treatment
    1 Other