BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON AC-POWERED PATIENT LIFT

    MDR report key: 2652703 · Received July 12, 2012

    Report

    Report Number
    3004493922-2012-00221
    Event Type
    Malfunction
    Date Received
    July 12, 2012
    Date of Event
    June 18, 2012
    Report Date
    July 11, 2012
    Manufacturer
    INVACARE SUZHOU
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO RMA HAS BEEN INITIATED FOR THIS ISSUE. MODEL 9805, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY ONE YEAR OLD. THE OWNER'S MANUAL PART NUMBER 1024492 REV E (MAY-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 IS UNKNOWN. THE MAINTENANCE HISTORY OF THE DEVICE IS UNKNOWN. THE CUSTOMER ALLEGED NO INJURY. THE CUSTOMER ALLEGED MALFUNCTION; WHEN THE LIFT IS AT THE UP POSITION IT GOES DOWN BY ITSELF EVEN WITHOUT ANYONE IN IT, GOES DOWN SLOWLY. THE USER ALSO ALLEGED THAT IF SOMEONE IS IN THE LIFT IS GOES DOWN FAST. THIS LIFT MALFUNCTION IS A POTENTIAL FOR FALL INJURY. MDR FILED.

    Description of Event or Problem · 1

    END USER STATES "THE LIFT BEING AT THE UP POSITION GOES DOWN BY ITSELF EVEN WITHOUT ANYONE IN THE LIFT. IT GOES ALL THE WAY DOWN SLOW WHEN NO ONE IS IN THE LIFT AND IF SOMEONE IS IN THE LIFT IT GOES DOWN FAST." 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 9805

    Patients

    Seq Age Sex Outcome Treatment
    1 Other