BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SARA 3000

    MDR report key: 3192557 · Received June 19, 2013

    Report

    Report Number
    3007420694-2013-00024
    Event Type
    Injury
    Date Received
    June 19, 2013
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. ZO.O.
    Product Code
    FNL
    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 (B)(4). IT WAS REPORTED A FEMALE PERSON WAS BEING TRANSFERRED WITH A SARA 3000 ACTIVE LIFTING DEVICE AND THAT DURING THIS TRANSFER HER LEGS WERE BUCKLED. LATER IT WAS FOUND SHE HAD SUSTAINED FRACTURES. THE INFORMATION PROVIDED, DESPITE OUR BEST EFFORTS, WAS LIMITED. WHEN REVIEWING SIMILAR REPORTED EVENTS, WE FOUND A NUMBER OF CASES WITH SIMILAR FAULT DESCRIPTIONS (FRACTURES), WHICH WERE FOUND TO MAINLY RELATE TO USER ERROR. (B)(4). THE DEVICE WAS PUT THROUGH A FUNCTION TEST BY THE ARJOHUNTLEIGH REP 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 PT HANDLING AND IN THAT WAY CONTRIBUTED TO THE EVENT. FROM OUR EVAL, IT APPEARS A NUMBER OF USER ERRORS HAVE CAUSED THE EVENT, THE MOST RELEVANT USER ERROR BEING A FAILURE TO EVAL THE PERSON TO BE TRANSFERRED BEFORE USE: NEED FOR THE PROFESSIONAL CLINICAL ASSESSMENT PRIOR TO THE USE OF SARA 3000 LIFT DEVICE IS STATED IN THE INSTRUCTIONS FOR USE (KKX81010M-EN ISSUE 7): "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." 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 USER ERROR AS THE RECEIVED INFORMATION AND OUR EVAL AS DESCRIBED 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

    REF IMP REPORT: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278793 SARA 3000 NONE FNL ARJOHUNTLEIGH POLSKA SP. ZO.O.

    Patients

    Seq Age Sex Outcome Treatment
    1