BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON AC-POWERED PATIENT LIFT

    MDR report key: 2832803 · Received November 14, 2012

    Report

    Report Number
    9616091-2012-00516
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Report Date
    November 13, 2012
    Manufacturer
    INVAMEX
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL RPA450-1, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 7 YEARS OLD. THE OWNER'S MANUAL WAS ISSUED WITH THIS DEVICE. 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. MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. DEALER STATES UNIT MOVES IN UP AND DOWN POSITION SOME OF THE TIME. UNIT CUTS OUT WHEN IN USE. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NON AC-POWERED PATIENT LIFT 880.5510 FSA INVAMEX RPA450-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other