BEUDAMED
    FDA Adverse Event Other Summary report: N

    SARA 3000

    MDR report key: 1748154 · Received December 16, 2009

    Report

    Report Number
    3004468271-2009-00030
    Event Type
    Other
    Date Received
    December 16, 2009
    Manufacturer
    MEDIBO N.V.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT SHOWS THAT THIS IS A PT WHO IS DIFFICULT TO PICK A STANDING LIFT. THIS SHOWS THE DATA ON THE SECOND LIFT MOVEMENT, WHERE THE PT CANNOT KEEP STANDING AND COULD NOT HOLD THE HANDLES. FOR THIS WE RECOMMEND THAT THE PT IS AGAIN ASSESSED TO DETERMINE WHETHER THIS PT IS APPROPRIATE TO CONTINUE WITH AN ACTIVE LIFTING HOIST. ALSO, THE CORRECT WAY OF RIGGING A SLING IN ACTIVE USE IS DESCRIBED ON THE PAGES 9-11. ON PAGE 12 IT STATES THAT THE LIFT CAN BE USED FOR PTS WHO ARE ABLE TO HOLD ON WITH AT LEAST 1 HAND. IT IS ALSO ADVISED TO HAVE PERSONS PRESENT TO INSTRUCT/INDICATE TO THE RESIDENT WHAT MOVEMENTS WILL BE PERFORMED. THE MANUFACTURER RECOMMENDS STAFF OBTAIN FURTHER INSTRUCTION REGARDING HOW THE TRANSFERS SHOULD BE DONE WITH THE PT AND THE IMPORTANCE OF PROPERLY ASSESSING IF THE RESIDENT IS STILL SUITABLE FOR LIFTING WITH A HOIST ACTIVE.

    Description of Event or Problem · 1

    DUE TO THIS BEING A RETROSPECTIVE REPORT AND ONLY PARTIAL INFO BEING AVAILABLE. THE ONLY DESCRIPTION OF EVENT IS "PATIENT SLING SLIPS ON THE FLOOR AND INJURING THEMSELVES." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SARA 3000 LIFT, PATIENT, NON-AC-POWERED FSA MEDIBO N.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other