BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAXILIFT

    MDR report key: 1894902 · Received January 28, 2010

    Report

    Report Number
    9617021-2010-00008
    Event Type
    Other
    Date Received
    January 28, 2010
    Date of Event
    January 12, 2010
    Report Date
    January 13, 2010
    Manufacturer
    ARJO MED AB LTD.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO WILL BE PROVIDED UPON CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    THE FACILITY REPORTS WHILE THE PT WAS BEING TRANSFERRED FROM HER BED TO A CHAIR, SHE SLIPPED OUT OF THE SLING. DETAILS OF PT AND INJURIES WERE NOT RELEASED. THE DEVICE WAS INSPECTED AND FOUND TO BE IN GOOD CONDITION. THERE WERE SOME SCRATCHES ON LEGS, AND THE CASTORS NEED TO BE REPLACED (NOT TURNING PROPERLY). THE LUG ATTACHMENTS WERE OK AND THE PIVOT HANGER BAR WAS IN GOOD CONDITION. THE SLING WAS ALSO INSPECTED AND WAS FOUND TO BE IN VERY GOOD CONDITION (ALMOST LIKE NEW). (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXILIFT LIFT, PATIENT, NON-AC-POWERED FSA ARJO MED AB LTD. 212000-06

    Patients

    Seq Age Sex Outcome Treatment
    1