BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON AC-POWERED PATIENT LIFT

    MDR report key: 2641551 · Received July 6, 2012

    Report

    Report Number
    3004493922-2012-00208
    Event Type
    Malfunction
    Date Received
    July 6, 2012
    Report Date
    July 5, 2012
    Manufacturer
    INVACARE SUZHOU
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - NO RMA HAS BEEN INITIATED FOR THIS ISSUE. HOWEVER, A QUOTE FOR THE RMA HAS BEEN PROVIDED - QT (B)(4). MODEL 9805, SERIAL NUMBER/DATE CODE (B)(4) IS APPROXIMATELY 7 MONTHS 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 DEALER CALLED STATING THAT THE PUMP ON THE 9805 HYDRAULIC LIFT WILL ALLEGEDLY NOT HOLD. THE LIFT WILL RAISE UP, BUT AS SOON AS PRESSURE IS APPLIED, IT WILL FALL BACK DOWN. REPLACEMENT ON QUOTE # (B)(4). THE DAMAGED PART IS TO BE RETURNED TO INVACARE FOR AN INSPECTION AND EVALUATION. NO INJURY ALLEGED.

    Description of Event or Problem · 1

    CUSTOMER STATES THAT THE PUMP WILL NOT HOLD, IT WILL RAISE UP, AS SOON AS PRESSURE IS APPLIED, IT WILL FALL BACK DOWN. QT # (B)(4). 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