BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLVO

    MDR report key: 1946048 · Received December 17, 2010

    Report

    Report Number
    8030916-2010-00038
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    February 4, 2009
    Report Date
    February 9, 2009
    Manufacturer
    LIKO AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS MDR IS PART OF A RETROSPECTIVE REVIEW IN ACCORDANCE WITH CAPA ACTIVITIES.

    Description of Event or Problem · 1

    FACILITY REPORTS THAT WHILE TRANSFERRING A RESIDENT FROM BED TO WHEELCHAIR USING A GOLVO MOBILE LIFT THAT THE RESIDENT FELL OUT OF THE SLING ONTO THE FLOOR. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOLVO NON-AC POWERED PATIENT LIFT FSA LIKO AB GOLVO 7007ES

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR