BEUDAMED
    FDA Adverse Event Other Summary report: N

    SARA PLUS

    MDR report key: 1748163 · Received December 16, 2009

    Report

    Report Number
    3004468271-2009-00042
    Event Type
    Other
    Date Received
    December 16, 2009
    Date of Event
    November 5, 2007
    Report Date
    November 20, 2007
    Manufacturer
    MEDIBO N.V.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LIFT WAS FOUND TO BE WORKING TO OEM SPEC. NO PICTURES OF A SARA PLUS WAS RECEIVED. THERE IS LITTLE INDICATION ON EXACTLY WHAT SLING WAS USED. LAST TRAINING DATE OF THE CAREGIVERS IS INDICATED TO HAVE BEEN (B)(6) 2007. FROM THE REPORT, THE COMMENT BY THE CAREGIVERS THAT THEY "PROBABLY SHOULD HAVE USED A MAXI LIFT" FOR THE TRANSFER PROVIDES THE INSIGHT THAT THERE WAS NO POSITIVE ASSESSMENT ON THE USE OF THE SARA PLUS WITH THIS PT BEFORE THE TRANSFER. THE SARA PLUS OPERATING AND PRODUCT CARE INSTRUCTIONS (OPI) CLEARLY STATE, "WARNING: ONLY USE THIS OR OTHER METHODS AFTER A SATISFACTORY PROFESSIONAL ASSESSMENT HAS BEEN CARRIED OUT ON THE INDIVIDUAL PT." ALSO THE CAREGIVERS COMMENTED THAT THE RESIDENT MIGHT HAVE BEEN TRYING TO ALLEVIATE PAIN FROM THE TRANSFER, AND THAT IN ORDER TO ALLEVIATE THIS PAIN THE RESIDENT MIGHT HAVE TRIED TO STEP OFF THE FOOT SUPPORT. FROM PAST OBSERVATIONS AND KNOWLEDGE OF BOTH THE PRODUCT AND END-USER POPULATION, THE MANUFACTURER IS AWARE OF THE FACT THAT, WHEN IN PAIN THE PERSON IN THE LIFT CAN HAVE THE REFLEX OF TRYING TO SIT BACK DOWN, AND MAKING (UNCONTROLLED) MOVEMENTS TO THAT EFFECT. THIS IS PRECISELY WHY THE LINES UNDER ABOVE ARE IN THE OPI. THE PT IS REPORTED TO HAVE "BEGAN SLIPPING OUT OF SLING". FROM PREVIOUS STIMULATION THE MANUFACTURER HAS ESTABLISHED THAT A PT CAN ONLY SLIP OUT OF A STANDARD ISSUE ACTIVE SLING IF THE CHEST SUPPORT STRAP HAS NOT BEEN APPLIED AS INSTRUCTED IN THE OPI. FROM THE INFO RECEIVED, THE MANUFACTURER CAN CONCLUDE THE FOLLOWING: THERE HAS BEEN NO REASONABLE SUGGESTION THAT EITHER THE PT OR THE CARER WAS HURT IN THIS INCIDENT. IT HAS BECOME APPARENT THAT THERE WAS A USE ERROR AND THE OPI WAS NOT FOLLOWED SINCE THERE DOES NOT APPEAR TO HAVE BEEN AN EVALUATION OF THE RESIDENT BEFORE THE TRANSFER TOOK PLACE. ALSO IT HAS BECOME APPARENT THAT THERE WAS A USE ERROR AND THE OPI WAS NOT FOLLOWED SINCE THE CHEST SUPPORT STRAP DOES NOT APPEAR TO HAVE BEEN CORRECTLY PUT IN PLACE. THIS IS THE ROOT CAUSE OF THE INCIDENT, IN THE OPINION OF THE MANUFACTURER. SINCE NO PROBLEMS OR DEFECTS OF A TECHNICAL STRUCTURAL NATURE COULD BE ESTABLISHED ON THE PRODUCT, AND THE ROOT CAUSE HAS BEEN ESTABLISHED TO BE USE ERROR, THE MANUFACTURER STRONGLY ADVISES THAT STAFF AT THE FACILITY THAT OPERATE THE EQUIPMENT BE RETRAINED IN ACCORDANCE WITH THE OPI.

    Description of Event or Problem · 1

    THE FACILITY REPORTS, DURING TRANSPORT, THE PT BEGAN SLIPPING OUT OF THE SLING. THE CAREGIVER WENT BEHIND THE PT AND UNBUCKLED HER, LOWERING HER TO THE FLOOR. A DIFFERENT LIFT WAS USED TO PICK UP THE PT. IT WAS NOTED THE RESIDENT HAD BEEN GIVEN MEDICATION BEFORE THE INCIDENT AND WAS SUFFERING FROM A PAINFUL FORM OF CELLULITIS. CAREGIVERS THOUGHT SHE MAY HAVE BEEN TRYING TO ALLEVIATE PAIN BY STEPPING OFF THE FOOT SUPPORT. THE CAREGIVERS THEMSELVES INDICATED THEY PROBABLY SHOULD HAVE USED A PASSIVE LIFT. THE LIFT AND SLING WERE INSPECTED AND FOUND TO BE IN GOOD CONDITION. THE LIFT WAS FUNCTIONING TO MANUFACTURER'S SPECIFICATIONS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SARA PLUS LIFT, PATIENT, NON-AC-POWERED FSA MEDIBO N.V. HEP0001-US

    Patients

    Seq Age Sex Outcome Treatment
    1