BEUDAMED
    FDA Adverse Event Other Summary report: N

    AC-POWERED PATIENT LIFT

    MDR report key: 2120493 · Received June 3, 2011

    Report

    Report Number
    1525712-2011-00232
    Event Type
    Other
    Date Received
    June 3, 2011
    Report Date
    June 2, 2011
    Manufacturer
    INVACARE
    Product Code
    FNG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SERIOUS INJURY ALLEGED. THE LIFT IS APPROXIMATELY 11 YEARS OLD WITH NO PREVIOUS COMPLAINTS. MAINTENANCE HISTORY IS UNKNOWN. THE SLING ALLEGEDLY RIPPED OFF THE HANGER BAR DURING A TRANSFER. MANUFACTURER OF SLING IS UNKNOWN. NATURE OF COMPLAINT SUGGESTS A TRANSFER ERROR AND/OR THE USE OF A NON-INVACARE ACCESSORY. CURRENT USER GUIDE COVERS PROPER TRANSFER METHODS AND HAS WARNINGS ON USING NON-INVACARE ACCESSORIES. PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION AT THIS TIME. FACILITY HAS REQUESTED AN IN-SERVICE. MDR FILED AS A CONSERVATIVE MEASURE.

    Description of Event or Problem · 1

    THE SLING ALLEGEDLY RIPPED OFF OF THE HANGER BAR AND THE AIDES DROPPED THE CONSUMER. NO SERIOUS INJURY IS ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AC-POWERED PATIENT LIFT 880.5500 FNG INVACARE RPA600

    Patients

    Seq Age Sex Outcome Treatment
    1