BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AC-POWERED PATIENT LIFT

    MDR report key: 2766206 · Received October 1, 2012

    Report

    Report Number
    3004493922-2012-00379
    Event Type
    Malfunction
    Date Received
    October 1, 2012
    Report Date
    September 29, 2012
    Manufacturer
    INVACARE SUZHOU
    Product Code
    FNG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) HAS BEEN INITIATED FOR THIS ISSUE. MODEL ROZE, SERIAL NUMBER/DATE (B)(4) IS APPROXIMATELY 1 YEAR OLD. THE OWNER'S MANUAL PART NUMBER 1150703, REV. C(JUL-11), 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 MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    A DEALER HAS REPORTED A REAR WHEEL THAT HAS DETACHED FROM THE LIFT. ALSO THE KNEE PADS WERE CRACKED AND THE PLASTIC AROUND THE KNEE PADS HAVE BROKEN LOOSE. THERE IS NO REPORT OF INJURY. THE DEVICE HAS BEEN REMOVED FROM USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AC-POWERED PATIENT LIFT 880.5500 FNG INVACARE SUZHOU ROZE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other