BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON AC-POWERED PATIENT LIFT

    MDR report key: 2393263 · Received December 30, 2011

    Report

    Report Number
    3004493922-2011-00063
    Event Type
    Malfunction
    Date Received
    December 30, 2011
    Report Date
    December 29, 2011
    Manufacturer
    INVACARE SUZHOU
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    RMA (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. MODEL ROZE, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 2 YEARS OLD. THE USER MANUAL PART NUMBER 1150703 WAS ISSUED WITH THIS DEVICE. THE USER MANUAL IS ALSO FOUND ON-LINE AT INVACARE.COM. IT IS UNKNOWN IF THE CONSUMER HAS FULLY READ AND UNDERSTANDS THE USER 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 CONSUMERS MEDICAL CONDITION, STABILITY AND MEDICATION REGIMEN ARE UNKNOWN . THE CONSUMERS AGE, HEIGHT AND WEIGHT ARE UNKNOWN. THE CONSUMERS TECHNIQUE WHILE USING THE DEVICE IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN.

    Description of Event or Problem · 1

    DEALER ALLEGES BROKEN BOLT SHEARED OFF IN MAST AT LIFT ARM WHILE BEING USED. NO INJURY ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NON AC-POWERED PATIENT LIFT 880.5510 FSA INVACARE SUZHOU ROZE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other