BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED PATIENT LIFT

    MDR report key: 2821827 · Received November 6, 2012

    Report

    Report Number
    9616091-2012-00496
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Report Date
    November 5, 2012
    Manufacturer
    INVAMEX
    Product Code
    FNG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL RPL450-1, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY FOUR YEAR OLD. THE OWNER'S MANUAL PART NUMBER 1078987 REV. I (JUN-06) 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 AND THE MAINTENANCE HISTORY OF THE DEVICE ARE UNKNOWN. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    (B)(4). THE PENDANT IS BEING QUOTED OUT. DEALER STATES WHEN THE LIFT IS TURNED ON IT STARTS RISING AUTOMATICALLY AND THEN THE USER SHAKES THE REMOTE AND PUSHES THE DOWN ARROW. BUT IN ORDER TO STOP IT FROM RISING THEY HAVE BEEN PUSHING ON THE RED EMERGENCY BUTTON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AC-POWERED PATIENT LIFT 880.5500 FNG INVAMEX RPL450-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other