BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2766186 · Received October 1, 2012

    Report

    Report Number
    9616091-2012-00405
    Event Type
    Malfunction
    Date Received
    October 1, 2012
    Date of Event
    September 12, 2012
    Report Date
    October 11, 2012
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) ISSUED MFR REPORT #9616091-2012-00405 INDICATING THE BRAND NAME AS POWERED WHEELCHAIR, THE COMMON DEVICE NAME AS 890.3860. THE CORRECT BRAND NAME IS MECHANICAL (MANUAL) WHEELCHAIR AND THE COMMON DEVICE NAME IS 890.3850. MDR DECISION DATE: (B)(6) 2012. (B)(4) NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL TRSX52FB, SERIAL NUMBER/DATE (B)(4) IS APPROXIMATELY TWO YEAR OLD. THE OWNER'S MANUAL PART NUMBER 1110550, 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 (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

    Additional Manufacturer Narrative · 1

    (B)(4). NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL TRSX52FB, SERIAL NUMBER/DATE CODE (B)(4)IS APPROXIMATELY TWO YEAR OLD. THE OWNER'S MANUAL PART NUMBER 1110550 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 (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

    ON (B)(6) - THE DEALER STATED THAT THE CONSUMER WAS SEATING IN THE TRSX52FB WHEELCHAIR WHEN THE RIGHT CROSSBRACE WELD WAS BROKEN. THERE WAS NO PATIENT INJURY REPORTED.

    Description of Event or Problem · 1

    (B)(4). THE DEALER STATED THAT THE CONSUMER WAS SEATING IN THE TRSX52FB WHEELCHAIR WHEN THE RIGHT CROSSBRACE WELD WAS BROKEN. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX TRSX52FB

    Patients

    Seq Age Sex Outcome Treatment
    1 45 DA Other