BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SARA 3000

    MDR report key: 2982176 · Received February 22, 2013

    Report

    Report Number
    3007420694-2013-00003
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 25, 2013
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. ZO.O.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY (B)(4) ON BEHALF OF THE IMPORTER (B)(6). THIS IS DECIDED TO BE A "MALFUNCTION" TYPE OF EVENT (H1) NOT BECAUSE THERE WAS A TECHNICAL MALFUNCTION OF THE DEVICE, BUT SINCE DUE TO A USE ERROR THE DEVICE DID NOT PERFORM AS INTENDED. WHEN REVIEWING SIMILAR REPORTABLE EVENTS, WE FOUND SOME CASES WITH SIMILAR FAULT DESCRIPTION (SLIPPING OUT OF THE SLING OR FROM THE FOOTPLATE RESULTING IN INJURIES), 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 WERE NOT ABLE TO FIND ANY DEFICIENCY WITH THE DEVICE. THIS MEANS THAT THE LIFTING SYSTEM WAS UP TO SPEC WHEN THE EVENT TOOK PLACE. THE DEVICE WAS BEING USED FOR PT HANDLING AND IN THAT WAY CONTRIBUTED TO THE EVENT. 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, THE NEED OF THE USE OF THE SLING CHEST STRAP IS ALSO DESCRIBED TO BE NECESSARY: E.G. "TO FASTEN THE SUPPORT STRAP SECURELY, PRESS THE BUCKLES (IF AVAILABLE) OR VELCRO (IF AVAILABLE) TOGETHER. THE STRAP SHOULD BE TIGHT, BUT COMFORTABLE FOR THE RESIDENT. REMEMBER TO TIGHTEN THE STRAP ONCE THE RESIDENT BECOMES LIFTED FROM THE CHAIR." WE HAVE NOT BEEN ABLE TO FIND ANY CONTRIBUTING MFG ANOMALIES. THE ROOT CAUSE OF THE COMPLAINT WAS FOUND TO BE A USE ERROR AS THE CITES ABOVE ARE SHOWING THAT IF THE IFU SAFETY WARNINGS ARE FOLLOWED THERE WILL BE NO PT OR CAREGIVER RISK.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE COMPANY REP: "RESIDENT WAS BEING ASSISTED IN SARA 3000 WITH 2 CERT NURSING AIDES TO BATHROOM. RESIDENT PASSED OUT WHILE IN STAND IN BATHROOM AND FELL OUT. RESIDENT APPARENTLY SLIPPED THRU THE SLING. BOTH LETS WERE BUCKLED WITH STRAPS AND SLING SECURED WITH BOTH BUCKLES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77371 SARA 3000 ACTIVE FLOOR LIFTS FSA ARJOHUNTLEIGH POLSKA SP. ZO.O.

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Other