BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SARA 3000

    MDR report key: 4189668 · Received October 17, 2014

    Report

    Report Number
    3007420694-2014-00103
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Report Date
    September 19, 2014
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. ZO.O.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WHEN REVIEWING SIMILAR REPORTABLE EVENTS, WE HAVE FOUND 6 CASES (INCLUDING THIS ONE) WITH SIMILAR EVENT INDICATION BY THE USER (UN-COMMANDED MOVEMENT OF THE SARA 3000 CAUSING INJURY). THE TREND OBSERVED FOR REPORTABLE COMPLAINTS WITH THE SARA 3000 DEVICES IN GENERAL IS CONSIDERED TO BE LOW AND STABLE, IN PARTICULAR WHEN COMPARED TO THE DAILY USE OF OVER 60,000 UNITS IN THE MARKET. WE HAVE NOT BEEN ABLE TO FIND ANY CONTRIBUTING MANUFACTURING ANOMALIES. FROM OUR EVALUATION, IT APPEARS A NUMBER OF USE ERRORS CAUSED THE EVENT. THE MOST RELEVANT USE ERROR BEING AN INCORRECT OPERATING WITH THE LEFT DEVICE AS IT IS STATED IN THE INSTRUCTION FOR USE. IT CLEARLY DEPICTS AND EXPLAINS THE USE OF THE SAFETY FEATURES THAT SARA 3000 LIFT IS EQUIPPED WITH AND WHICH CAN BE USED IN THE SITUATIONS WHEN SOME PARTS ARE MALFUNCTIONING CAUSING FOR EXAMPLE UN-COMMANDED MOVEMENTS HAVE BEEN USED. THE DEVICE WAS FOUND NOT TO BE TO THE SPECIFICATION, WHILE IT WAS BEING USED FOR PATIENT TREATMENT. THE DEVICE PLAYED A ROLE IN THE EVENT DUE TO A MALFUNCTION ALTHOUGH OUR INVESTIGATION SHOWS THAT ANY RISK WAS PRESENT NOT DUE TO THE MALFUNCTION BUT DUE TO THE CAREGIVER STAFF NOT FOLLOWING THE INSTRUCTIONS FOR USE AS SUPPLIED WITH THE DEVICE. CAREGIVERS RATHER THAN TRYING TO UNHOOKED THE PATIENT FROM THE SLING AND LOWERED HIM ON THE FLOOR SHOULD STOP THE DEVICE USING EMERGENCY STOP AND LOWER THE PATIENT ON THE CHAIR OR COMMODE USING EMERGENCY LOWERING. IN CONCLUSION, THE ROOT CAUSE OF THE COMPLAINT WAS FOUND TO BE A USE ERROR RELATING TO THE DEVICE'S OPERATING AS THE RECEIVED INFO AND OUR EVALUATION AS DESCRIBED ABOVE ARE SHOWING THAT IF THE INSTRUCTIONS FOR USE HAD BEEN FOLLOWED, THE EVENT COULD HAVE BEEN AVOIDED. BASED ON THE ABOVE, IT APPEARS THE DEVICE MALFUNCTION BY ITSELF DID NOT DIRECTLY CAUSE AN INJURY TO THE CAREGIVER BUT IT WAS CAUSED BY USE ERROR: OFF-LABEL USE. WE FIND THIS COMPLAINT TO BE REPORTABLE TO THE COMPETENT AUTHORITIES. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DUE TO A HANDSET MALFUNCTION, AN UN-COMMANDED MOVEMENT OCCURRED, THE LIFTING OPERATION COULD NOT BE STOPPED. THE CAREGIVER UNHOOKED THE PATIENT FROM THE DEVICE LOWERING HER TO THE FLOOR. THIS CAUSED THE PATIENT TO BE IN AN AWKWARD POSITION WITH HER LEGS CRUMPLED BENEATH HER. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662053 SARA 3000 NI FSA ARJOHUNTLEIGH POLSKA SP. ZO.O. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other