BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SARA 3000

    MDR report key: 3004019 · Received March 12, 2013

    Report

    Report Number
    3007420694-2013-00008
    Event Type
    Injury
    Date Received
    March 12, 2013
    Report Date
    February 11, 2013
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. ZO.O.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER (B)(4) BY ARJOHUNTLEIGH (B)(4) ON BEHALF OF THE IMPORTER (B)(4). 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 2000 IS CONSIDERED TO BE LOW AND STABLE. WE WERE NOT ABLE TO FOUND 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 APPEAR TO HAVE CAUSE 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 (KKK81010M-EN ISSUE 4): 'WARNING: BEFORE ATTEMPTING TO RAISE A RESIDENT, A FULL CLINICAL ASSESSMENT OF THE RESIDENT'S CONDITION AN 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." NOTE THAT IN THIS CASE THERE IS NO INDICATION OF A DROP OUT OF THE SLING. INDICATING THE SLING WAS USED AND THE SLING CHEST STRAP WAS IN PLACE. 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

    AN INCIDENT WITH A SARA 3000 WAS REPORTED BY THE CUSTOMER. ACCORDING TO THE DETAILS PROVIDED BY THE ARJOHUNTLEIGH REPRESENTATIVE: "THE RESIDENT WAS BEING TRANSFERRED FROM THE TOILET TO THE CHAIR WHEN SHE SUDDENLY GOT WEAK AND UNRESPONSIVE. STAFF EASED HER TO THE FLOOR. IT WAS REPORTED THAT: AT THE TIME THERE WERE NO BRUISING OR BUMPS, THE RESIDENT DENIED ANY PAIN BUT STATED HER RIGHT SHOULDER HURT. THE RESIDENT WAS PUT BACK TO BED. THE DOCTOR WAS IN THE BUILDING AND ASSESSED THE RESIDENT AND THE RIGHT SHOULDER COULD NOT BE MOVED WITHOUT CAUSING PAIN. THE RESIDENT WAS SENT TO THE HOSPITAL FOR ASSESSMENT TO SHOULDER.'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103553 SARA 3000 ACTIVE FLOOR LIFTS FSA ARJOHUNTLEIGH POLSKA SP. ZO.O. HEA0002-US

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization