BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SARA 3000

    MDR report key: 3192585 · Received June 19, 2013

    Report

    Report Number
    3007420694-2013-00031
    Event Type
    Malfunction
    Date Received
    June 19, 2013
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. ZO.O.
    Product Code
    FRW
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH (B)(4) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. (B)(4). THIS APPEARS TO BE A "MALFUNCTION" TYPE OF EVENT NOT BECAUSE THERE WAS A TECHNICAL MALFUNCTION OF THE DEVICE, BUT SINCE DUE TO A USE ERROR THE DEVICE PERFORM AS INTENDED. IT WAS REPORTED A PERSON WAS BEING TRANSFERRED WITH A SARA 3000 ACTIVE LIFTING DEVICE AND THAT DURING THIS TRANSFER THE KNEE SUPPORT TILTED AND HER FEET SLIPPED FROM FOOT SUPPORT. THE CAREGIVER WHO WAS HELPING TO PUT THE FEET BACK HAS LATER SUSTAINED BACK PAIN. THE INFORMATION PROVIDED SHOWS THAT IT WAS AN ERROR WITH POSITIONING THE PATIENT ON THE DEVICE. WHEN REVIEWING REPORTED EVENTS, WE HAVEN'T FOUND ANY CASES WITH SIMILAR FAULT DESCRIPTION (KNEE SUPPORT MISUSE). THERE IS TREND OBSERVED FOR REPORTABLE COMPLAINTS ON SARA 3000 BUT IS CONSIDERED TO BE LOW AND STABLE TAKING ONTO CONSIDERATION ABOUT 50000 UNITS ON FIELD. THE TREND IS NOT RELATED WITH THIS FAILURE MODE. THE DEVICE WAS PUT THROUGH A FUNCTION TEST BY THE ARJOHUNTLEIGH REPRESENTATIVE THAT VISITED THE SITE. WE WERE NOT ABLE TO FIND ANY DEFICIENCY WITH THE DEVICE. THIS MEANS THAT THE LIFTING SYSTEM WAS UP TO SPECIFICATION WHEN THE EVENT TOOK PLACE. THE DEVICE WAS BEING USED FOR PATIENT HANDLING AND IN THAT WAY CONTRIBUTED TO THE EVENT. FROM OUR EVALUATION IT APPEARS A NUMBER OF USE ERRORS HAVE CAUSED THE EVENT, THE MOST RELEVANT USE ERROR BEING A FAILURE TO POSITIONING THE PERSON TO BE TRANSFERRED BEFORE USE: WHEN THE CORRECT PROCEDURE IS FOLLOWED THERE APPEARS TO KNEE SUPPORT CANNOT TILT. NEED TO POSITION THE PATIENT ON THE LIFT PRIOR TO USE OF SARA 3000 LIFT DEVICE IS STATED IN THE INSTRUCTION FOR USE (KKX81010M-EN ISSUE 7): WHEN THE RESIDENT IS READY, HELP OR ALLOW THE RESIDENT TO PLACE HIS/HER FEET ON THE FOOT SUPPORT. PUSH THE SARA 3000 TOWARD THE RESIDENT TO EASILY ASSIST WITH THIS. CAREFULLY PUSH THE SARA 3000 IN CLOSER TO MAKE FULL LOWER LEG CONTACT WITH THE KNEE SUPPORT. WHEN USING THE STANDING SLING, THE RESIDENT CAN BE RAISED TO A FULLY STANDING POSITION. WARNING: THE RESIDENT'S FEET SHALL ALWAYS REMAIN IN FULL CONTACT WITH THE FOOT SUPPORT. WHEN RAISING, CHECK TO ENSURE THAT THE RESIDENT'S FEET DO NOT LIFT FROM THE FOOT SUPPORT. IF THEY DO, LOWER THE RESIDENT IMMEDIATELY UNTIL RESIDENT'S FEET FULLY REACH THE FOOT SUPPORT. WE HAVE NOT BEEN ABLE TO FIND ANY CONTRIBUTING MANUFACTURING ANOMALIES. THE ROOT CAUSE OF THE COMPLAINT WAS FOUND TO BE A USE ERROR AS THE RECEIVED INFORMATION AND OUR EVALUATION AS DESCRIBED ABOVE ARE SHOWING THAT IF THE IFU SAFETY WARNINGS ARE FOLLOWED THERE WILL BE NO PATIENT OR CAREGIVER RISK.

    Description of Event or Problem · 1

    REF # IMP (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279448 SARA 3000 NONE FRW ARJOHUNTLEIGH POLSKA SP. ZO.O.

    Patients

    Seq Age Sex Outcome Treatment
    1