BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SARA 3000

    MDR report key: 2123084 · Received November 24, 2008

    Report

    Report Number
    3004468271-2008-00016
    Event Type
    Injury
    Date Received
    November 24, 2008
    Date of Event
    October 11, 2008
    Report Date
    November 24, 2008
    Manufacturer
    MEDIBO N.V.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATOR REPORTED THAT NO SPECIFIC ALLEGATION OF DEFICIENCY WAS MADE BY THE CUSTOMER OR DISCOVERED ON SITE BY THE RPTR. NO PICTURES WERE REC'D. NO SLING OR OTHER ACCESSORY APPEARS TO HAVE BEEN INVOLVED IN THE INCIDENT. NO TRAINING DATE COULD BE GIVEN FOR THE OPERATOR OF THE LIFT. NO INDICATION COULD BE GIVEN OF THE MENTAL AND PHYSICAL STATE OF THE PT. THERE APPEARS TO BE NO CAUSAL LINK BETWEEN THE USE OF THE DEVICE AND THE EVENT. THE SARA 3000'S FOOT SUPPORT IS FIXED AND DOES NOT MOVE. THE ONLY MOVING PARTS ON THE SARA 3000 ITSELF ARE THE LIFTING ARMS. SINCE THE FOOT SUPPORT DOES NOT MOVE, THE LIFT COULD NOT HAVE PUSHED OR CATAPULTED THE RESIDENT. ALTHOUGH NOT INDICATED, IT IS POSSIBLE THE RESIDENT WAS SOMEWHAT COMBATIVE AND PUSHED HERSELF BACKWARD OVER THE WHEELCHAIR BACK SUPPORT. THE OPERATING AND PRODUCT CARE INSTRUCTIONS STATE THAT BEFORE EACH TRANSFER, THE RESIDENT IS TO BE EVALUATED FOR SUITABILITY. THIS IS THE FIRST SUCH INCIDENT OF THIS TYPE REPORTED TO THE MFR. THE MFR CONCLUDES THIS EVENT COULD NOT LEAD TO A SERIOUS INJURY OR DEATH AND WAS LIKELY TO HAVE BEEN BROUGHT UPON BY THE INCORRECT OR UNEXECUTED ASSESSMENT OF THE RESIDENT FOR SUITABILITY. THE MFR RECOMMENDS OPERATORS ARE RETRAINED TO THE REQUIREMENTS OF THE OPI.

    Description of Event or Problem · 1

    FACILITY REPORTED THAT A RESIDENT WAS SEATED IN A WHEELCHAIR, WITH LOCKED BRAKES. THE RESIDENT WAS PREPARED TO BE TRANSFERRED WITH THE SARA 3000. THE SARA 3000 ALSO HAD THE BRAKES (AT THE REAR WHEELS) APPLIED. THE RESIDENT PUT HER OWN FOOT ON THE SARA 3000 FOOT SUPPORT, BUT NEEDED HELP WITH THE OTHER FOOT. WHEN THE CAREGIVER KNEELED DOWN TO HELP, THE RESIDENT SPONTANEOUSLY BEGAN TO STRETCH HERSELF AND FELL BACKWARD, WHEELCHAIR AND ALL. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention