BEUDAMED
    FDA Adverse Event Other Summary report: N

    SARA PLUS

    MDR report key: 2957388 · Received October 19, 2007

    Report

    Report Number
    3004468271-2007-00005
    Event Type
    Other
    Date Received
    October 19, 2007
    Date of Event
    September 15, 2007
    Report Date
    October 19, 2007
    Manufacturer
    MEDIBO N.V.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LIFTER WAS INSPECTED BY AN ARJO INVESTIGATOR; THE DEVICE WAS FOUND TO BE IN VERY GOOD CONDITION OVERALL. THE RIGHT REAR CASTOR WAS NOISY, BUT THIS DID NOT AFFECT THE FUNCTION OF THE LIFT. THERE WAS ALSO A BLUE PAINT MARK ON THE LEG. PICTURES OF THE LIFT SHOWED THE PADDING AROUND THE REAR OF THE KNEE SUPPORT WAS INTACT AND IN PLACE. THE LIFT WAS FUNCTION TESTED AND FOUND TO BE WORKING NORMALLY. NO TRAINING DATE COULD BE GIVEN FOR THE CARE PERSONNEL. THE LIFTER OPERATING INSTRUCTIONS CLEARLY STATE, "WARNING: IT IS ADVISABLE TO FAMILIARIZE YOURSELF AND UNDERSTAND THE OPERATION OF THE VARICUS CONTROLS AND FEATURES OF THE (LIFT) AS DESCRIBED IN THE PRODUCT DESCRIPTION/FUNCTION SECTION IN THIS MANUAL AND ENSURE THAT ANY ACTION OR CHECK SPECIFIED IS CARRIED OUT BEFORE COMMENCING TO LIFT A PATIENT." IT ALSO STATES, "SARA PLUS SHALL ALWAYS BE HANDLED BY A TRAINED CAREGIVER AND IN ACCORDANCE WITH THE INSTRUCTIONS OUTLINED IN THESE OPERATING AND PRODUCT CARE INSTRUCTIONS." FROM A SIMULATION OF THE EVENT, IT APPEARS THAT THE PATIENT RAISED ONE WEIGHT-BEARING LEG, LIFTED IT APPROXIMATELY 20 CM OFF THE FOOTPLATE, SHIFTING WEIGHT TO THE OTHER LEG, SWINGING THE FREE LEG BACKWARD, SIDEWAYS, FORWARD, AND BACKWARD AGAIN WITH CONSIDERABLE FORCE IN ORDER TO PRODUCE A MASSIVE HEMATOMA BY HITTING HIS CALF AGAINST THE KNEE SUPPORT ADJUSTMENT. THIS TYPE OF ACTION DOES NOT APPEAR TO CONSTITUTE A "SLIGHT" AGITATION FOR (B)(6) PATIENT, AS WAS REPORTED BY THE FACILITY. THE OPERATING INSTRUCTIONS CLEARLY STATE, "WARNING: ONLY USE THIS OR OTHER METHODS AFTER A SATISFACTORY PROFESSIONAL ASSESSMENT HAS BEEN CARRIED OUT ON THE INDIVIDUAL PATIENT." FROM THE INFORMATION RECEIVED AND THE SIMULATION OF THE EVENT, THE MANUFACTURER CONCLUDES THE ROOT CAUSE OF THIS INCIDENT WAS DUE TO INSUFFICIENT KNOWLEDGE OF THE DEVICE BY THE OPERATORS. THE MANUFACTURER STRONGLY SUGGESTS THE STAFF AT THE FACILITY THAT USE THE LIFTER BE RETRAINED AGAINST THE OPERATING INSTRUCTIONS. FROM THE CONCLUSIONS OF THIS COMPLAINT, NO CORRECTIVE ACTON CAN BE BUILT TOWARDS THE PRODUCT. HOWEVER, THE MANUFACTURER WILL CONTINUE TO MONITOR COMPLAINTS FOR POSSIBLE FUTURE ACTIONS.

    Description of Event or Problem · 1

    THE FACILITY REPORTS THE PATIENT WAS SITTING IN THE CHAIR. USING THE LIFTER, THE STAFF BEGAN TO RAISE HIM FOR TRANSFER TO THE COMMODE. AS HE WAS STANDING, THE PATIENT BECAME SLIGHTLY AGITATED. HIS FOOT CAME OFF THE FOOT PLATE AND WENT AROUND BEHIND THE KNEE SUPPORT. THIS IS WHEN THE INJURY OCCURRED. THE RESIDENT SUSTAINED A HEMATOMA ON HIS LEFT CALF AREA WHICH REQUIRED SURGERY TO DRAIN. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SARA PLUS STANDING AND RAISING AID FSA MEDIBO N.V. HEPXXXX

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization