BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2798494 · Received October 22, 2012

    Report

    Report Number
    1531186-2012-01238
    Event Type
    Malfunction
    Date Received
    October 22, 2012
    Report Date
    October 19, 2012
    Manufacturer
    UNKNOWN
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL TREX2 SERIAL NUMBER/DATE CODE IS UNKNOWN AND IS OF AN UNKNOWN AGE. THE OWNER'S MANUAL PART NUMBER 110546 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) ISSUED MFR. REPORT # 1531186-2012-01238 INDICATING THE FDA REGISTRATION NUMBER AS 1531186. THE CORRECT REGISTRATION NUMBER IS 1525712. (B)(4) - NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL TREX2 SERIAL NUMBER/DATE CODE IS UNKNOWN AND IS OF AN UNKNOWN AGE. THE OWNER'S MANUAL PART NUMBER 110546 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' TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. THE MALFUNCTION HAS NO...

    Description of Event or Problem · 1

    A REPORT HAS BEEN RECEIVED FROM A DEALER STATING UPHOLSTERY RIPPING. NO INJURY. THE PART HAS BEEN REPLACED WITHOUT FURTHER INCIDENT.

    Description of Event or Problem · 1

    A REPORT HAS BEEN RECEIVED FROM A DEALER STATING UPHOLSTERY RIPPING. NO INJURY. THE PART HAS BEEN REPLACED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR UNKNOWN TREX2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other