BEUDAMED
    FDA Adverse Event Other Summary report: N

    SARA 3000

    MDR report key: 1748152 · Received December 16, 2009

    Report

    Report Number
    3004468271-2009-00043
    Event Type
    Other
    Date Received
    December 16, 2009
    Date of Event
    January 9, 2007
    Report Date
    January 9, 2007
    Manufacturer
    MEDIBO N.V.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PICTURES OR PARTS WERE MADE AVAILABLE TO THE MANUFACTURER. THE LIFT WAS LAST SERVICED IN (B)(4) 2006. THE DEVICE WAS NOT EXAMINED WITHIN A SIX OR 12-MONTH INTERVAL, OR IN ACCORDANCE WITH AN EXAMINATION SCHEME. THE OPI CLEARLY INDICATES HOW THE LIFT AND ACCESSORIES ARE TO BE EXAMINED AND MAINTAINED, FROM DAILY CHECKS ONWARDS. THE LIFT HAS BEEN FOUND WITH DEFECTIVE HAND GRIPS. THESE ARE METAL GRIPS FORMING ONE SINGLE PIECE WITH THE LIFTING ARMS BY MANNER OF A WELD. OVER THE EXTREMITIES OF THE HAND GRIPS, A RUBBER PIECE IS FIXATED ON EACH SIDE TO GIVE BETTER GRIP TO THE RESIDENT. IN THE REPORT, IT INDICATES THAT "THE ENDS OF BOTH HAND GRIPS HAVE BROKEN OFF, AND THAT THE HAND GRIPS ARE WORN PARTS ORDERED TO BE REPLACED. IT IS INDICATED THAT HOIST ATTACHMENT CLIPS ARE VERY SLIGHTLY WORN BUT FUNCTION CORRECTLY. THE SLING CLIPS ARE JUDGED TO BE POSITIVE. THE DHR OF THE LIFT INDICATES THAT THE SLING USED IS THAT ORIGINALLY SUPPLIED WITH THE LIFT. THERE IS NO INDICATION IN THE REPORT OF OTHER SLINGS BEING USED THAT THE REPORTED ONE. THE OPI CLEARLY STATES, "VISUALLY CHECK SLING ATTACHMENT POINTS. DO NOT USE IF DAMAGED." THE SLING INVOLVED IS REPORTED TO HAVE SOME WEAR TO THE BACK PAD AND TO HAVE "TORN STITCHING TO THE LEFT HAND SIDE PADDING, APPARENTLY MADE WORSE BY MAINTENANCE ENGINEER ON INSPECTION." IT IS CLEARLY STATED IN THE OPI TO "EXAMINE THE SLING FOR DAMAGE OR FRAYING A REQUIRED." OUT OF THE DESCRIPTION, THE TESTING DOCUMENTED IN THE MOVIE FILES APPEARS THAT THE INCIDENT WAS CAUSED BY: THE RESIDENT DID NOT OR WAS NOT ABLE TO HOLD ON TO THE HANDGRIPS OF THE LIFTING ARMS WITH ONE OR TWO HANDS, AS DESCRIBED IN THE OPERATING AND PRODUCT CARE INSTRUCTIONS. (CFR. ALSO POINT 10). UNDER THE "INVESTIGATION" SECTION OF THIS DOCUMENT. THE RESIDENT WAS RAISED WITH A SLING THAT APPEARS TO HAVE BEEN TOO SMALL FOR HER.

    Description of Event or Problem · 1

    THE FACILITY REPORTS THE CARER PUT THE PT INTO THE SLING IN PREPARATION FOR TRANSFERRING THE PT FROM CHAIR TO BED. THE RGN ENTERED THE ROOM TO HELP WITH THE TRANSFER. BOTH ADMIT THE STRAPS WERE NOT CHECKED. THE REMOTE HANDSET WAS USED TO RAISE THE PT. WHEN APPROX 12 INCHES OFF THE CHAIR, THE PT SLID THROUGH THE SLING (THE BODY STRAPS HAVE BEEN INDICATED TO HAVE BEEN DONE UP). THE PT ENDED UP SITTING BACK ON THE CHAIR WITH BOTH ARMS STILL IN THE SLING BUT ABOVE HER HEAD, THE SLING HAVING RISEN ABOVE HER ARM SOCKETS. (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. HEA0002

    Patients

    Seq Age Sex Outcome Treatment
    1 Other