BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE 9000

    MDR report key: 3201481 · Received June 27, 2013

    Report

    Report Number
    3007420694-2013-00028
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 19, 2013
    Report Date
    May 29, 2013
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. ZO.O.
    Product Code
    FNL
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER (B)(4) BY ARJOHUNTLEIGH ON BEHALF OF THE MFR ARJOHUNTLEIGH (B)(4). THE PRODUCT INVOLVED IN THE INCIDENT IS AN (B)(4), WHICH WAS MANUFACTURED ON 24-JAN-2013. THE DEVICE HISTORY RECORD HAS BEEN REVIEWED; NO ANOMALIES WERE RECORDED ON THE RECORD AT THE TIME OF MANUFACTURE, ALSO ONE OF THE REQUIREMENTS OF THE WORK INSTRUCTIONS AND QUALITY PROCEDURES IS FOR THE DEVICE TO HAVE A 100% FUNCTIONALITY TEST ON SAFETY SIDE PANELS BEFORE THEY ARE CLEARED FOR DISPATCH. THE DEVICE WAS INSPECTED AT THE USER'S FACILITY BY OUR REP. OUR REP WAS ADVISED THAT; AT SOME TIME PRIOR TO THE INCIDENT, THE CUSTOMER HAD USED A LUBRICANT ON THE SAFETY SIDE PINS AND THIS WAS EVIDENT DURING THE INSPECTION OF THE DEVICE. OUR REPS INSPECTION DID NOT REVEAL ANY WORN OR DAMAGED PARTS, ALSO ALL SAFETY SIDE SYSTEM FUNCTIONS OPERATE NORMALLY AND SAFETY SIDE LOCKING MECHANISM OPERATED TO THE DESIGN SPECIFICATION; ALL FUNCTIONS OF THE SIDE RAIL WORKED NORMALLY THROUGH EXTENSIVE TESTING, FREEDOM OF MOVEMENT OF THIS RIGHT SIDE RAIL ACTED SIMILARLY TO THE LEFT SIDE RAIL. THE SAFETY SIDE LOCKED INTO POSITION EVERY TIME, THE FAILURE COULD NOT BE DUPLICATED. WE CAN ONLY PRESUME THAT THE SAFETY SIDE LOCKING MECHANISM HAD NOT BEEN SECURELY ENGAGED IN THE RAISED POSITION, IN SUMMARY, THE DEVICE WAS BEING USED AT THE TIME OF THE EVENT, IT FAILED TO MEET ITS SPECIFICATIONS AS IT SUFFERED A MALFUNCTION DUE TO A USE ERROR, AND IN DOING SO IT CONTRIBUTED TO THE OUTCOME OF THE EVENT: THE SAFETY SIDE DROPPED DOWN AND THE RESIDENT FELL TO THE FLOOR. WE DO ADVICE IN SECTION 8, CARE AND PREVENTATIVE MAINTENANCE OF THE USER MANUAL 746-579 WHICH STATES THE "OPERATION OF THE SAFETY SIDES TO BE CHECKED ON A WEEKLY BASIS". ALSO WHEN USING THE SAFETY SIDE THE USER SHOULD ALWAYS ENSURE THAT THE LOCKING MECHANISM IS SECURELY ENGAGED, THIS IS ALSO COVERED IN CORRECT USE OF THE SAFETY SIDE IN SECTION 4 OF THE USER MANUAL AND THERE IS ALSO WARNING TO "ENSURE THAT THE LOCKING MECHANISM IS SECURELY ENGAGED WHEN THE SAFETY SIDES ARE LEFT IN THE RAISED POSITION." WE HAVE REVIEWED OUR POST MARKET SURVEILLANCE TRENDING ANALYSIS AND WE DO NOT HAVE ANY ADVERSE TRENDS FOR THIS FAILURE MODE. (B)(4). WE SHALL CONTINUE TO MONITOR FOR ANY FURTHER COMPLAINTS OF THIS NATURE TO DETERMINE TRENDING, NO FURTHER ACTIONS PROPOSED AT THIS TIME.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294230 ENTERPRISE 9000 FNL ARJOHUNTLEIGH POLSKA SP. ZO.O.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other