BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SARA 3000

    MDR report key: 2890658 · Received December 20, 2012

    Report

    Report Number
    3007420694-2012-00059
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 17, 2012
    Report Date
    November 19, 2012
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. Z O.O.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH POLSKA SP.ZO.O. ON BEHALF OF THE IMPORTER (B)(4). PLEASE NOTE THAT PREVIOUS MEDWATCH REPORTS FOR THIS PRODUCT MAY HAVE BEEN SUBMITTED FOR THE MFG SITE MEDIBO MEDICAL PRODUCTS NV. AS OF (B)(4) 2012, THAT NUMBER WAS DE-ACTIVATED DUE TO THE SITE NO LONGER BEING A MFR. GOING FORWARD, COMPLAINTS RELATED TO THIS PRODUCT ARE TO BE HANDLED BY ARJOHUNTLEIGH POLSKA SP. ZO.O. AND ANY MEDWATCH REPORTS WILL BE SUBMITTED. WHEN REVIEWING SIMILAR REPORTABLE EVENTS, WE FOUND SOME CASES WITH SIMILAR FAULT DESCRIPTION (SLIPPING OUT OF THE SLING OR FROM THE FOOTPLATE RESULTING IN BROKEN BONES), WHICH WERE FOUND TO MAINLY RELATED TO USE ERROR. THE TREND OBSERVED FOR REPORTABLE COMPLAINTS WITH THIS FAILURE MODE ON SARA 3000 IS CONSIDERED TO BE LOW AND STABLE. WE HAVE FOUND A DEFICIENCY WITH THE DEVICE WHICH MIGHT HAVE ATTRIBUTED TO, BUT IS UNLIKELY TO HAVE BEEN THE ROOT CAUSE OF THE INCIDENT - LACK OF THE BUCKLE ON ONE OF THE LEG STRAPS. IT IS AN ACCESSORY THERE TO HOLD THE LEGS IN PLACE, TO BE USED AFTER THE JUDGMENT OF MEDICALLY QUALIFIED PERSON. FROM OUR EVAL, IT APPEARS A NUMBER OF USE ERRORS, APPEAR TO HAVE CAUSED THE EVENT, THE MOST RELEVANT USE ERROR BEING A FAILURE TO EVALUATE THE PERSON TO BE TRANSFERRED BEFORE USE: NEED FOR THE PROFESSIONAL CLINICAL ASSESSMENT PRIOR TO USE OF SARA 3000 LIFT DEVICE IS STATED IN THE INSTRUCTION FOR USE (KKX81010M-EN ISSUE 4): 'WARNING: BEFORE ATTEMPTING TO RAISE A RESIDENT, A FULL CLINICAL ASSESSMENT OF THE RESIDENT'S CONDITION AND SUITABILITY MUST BE CARRIED OUT BY A QUALIFIED PERSON ON THE INDIVIDUAL RESIDENT TO DETERMINE IF IT IS ADVISABLE THAT HE OR SHE WILL BE LIFTED USING A SARA 3000 STANDING AND RAISING AID.' ADDITIONALLY USE OF THE LOWER LEG STRAP IS ALSO DESCRIBED: 'WARNING: AN ASSESSMENT MUST BE MADE FOR EACH INDIVIDUAL RESIDENT BEING RAISED BY THE SARA 3000 -BY A MEDICALLY QUALIFIED PERSON- AS TO WHETHER THE RESIDENT REQUIRES THE LOWER LEG STRAPS WHEN USING THE STANDING SLING. USE IF NECESSARY, E.G. WITH UNRULY RESIDENTS, RESIDENTS WITH SPASMS, ETC. THAT WERE ASSESSED AS SUITABLE TO BE RAISED WITH THE SARA 3000.' WE CONCLUDE THE ROOT CAUSE OF THE FAILURE WAS USE ERROR.

    Description of Event or Problem · 1

    PER (B)(4) SERVICE TECH EVENT DESCRIPTION OF IDF: "CAREGIVER WAS GETTING READY TO TRANSFER PT. LIFT ARMS WERE UPRIGHT AND PT WAS STANDING IN LIFTING POSITION WITH SLING AROUND THE BACK OF THE SHOULDERS. PT'S RIGHT FOOT SLIP OFF THE LIFT FOOT PLATFORM AND THE PT FELL TO HER RIGHT SIDE FRACTURING HER LEFT HUMERUS CAUSED BY THE SLING UNDER HER LEFT ARM PIT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SARA 3000 ACTIVE FLOOR LIFTS FSA ARJOHUNTLEIGH POLSKA SP. Z O.O. HEA0002-US

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization