BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENTERPRISE 9000

    MDR report key: 3383683 · Received August 21, 2013

    Report

    Report Number
    3007420694-2013-00040
    Event Type
    Other
    Date Received
    August 21, 2013
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. Z.O.O.
    Product Code
    FNL
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). OUR REP HAS VISITED THE FACILITY TO INVESTIGATE; THE NURSING ASSISTANT WAS INTERVIEWED WHO STATED THAT THE PT WAS BEING CLEANED AND DURING THIS PROCESS THE PT WAS ROLLED ON HIS LEFT SIDE AGAINST THE LEFT SIDE RAIL. THE LEFT SIDE RAIL GAVE WAY (COLLAPSED) ALLOWING THE PT TO FAIL TO THE FLOOR LEADING TO THE DESCRIBED INJURIES TO HIS HEAD AND THE RIGHT SIDE OF HIS BODY. UNFORTUNATELY WE HAVE BEEN UNABLE TO INSPECT THE ACTUAL BED INVOLVED IN THE INCIDENT AS NO RECORD WAS MADE OF THE SERIAL NUMBER OR ASSET NUMBER OF THE BED AND WITHOUT THIS INFO WE HAVE BEEN UNABLE TO VERIFY THE CAUSE. ALTHOUGH WE DO KNOW THAT THE PRODUCT INVOLVED IN THE INCIDENT WILL HAVE BEEN AN ENTERPRISE (B)(4), AS THE BEDS AT THE FACILITY ARE PART OF A GROUP OF BEDS SOLD TO THE (B)(6)AT THE SAME TIME EARLIER THIS YEAR. WE KNOW THAT ALL THE BEDS WERE SUBJECTED TO THE SAME LEVEL OF SCRUTINY PRIOR TO DISPATCH I.E. ONE OF THE REQUIREMENTS OF THE WORK INSTRUCTIONS AND QUALITY PROCEDURES FOR THE DEVICES IS THE 100% FUNCTIONALITY TEST OF THE SAFETY SIDE PANELS BEFORE THEY ARE CLEARED FOR DISPATCH. THIS IS THE THIRD INCIDENT AT THIS FACILITY, EACH TIME WE HAVE NOT BEEN ABLE TO FIND ANY CONTRIBUTING MFG ANOMALIES. THE ONLY ANOMALY THAT WE ARE AWARE OF IS THERE TO DO SEEM TO BE ISSUES WITH THE CLEANLINESS OF THE BEDS, IN PARTICULAR WITH THE SAFETY SIDES HAVING BODY FLUIDS AND FOOD DEBRIS OVER THEM ON SOME OF THE BEDS WHICH COULD CAUSE ISSUES WITH LOCKING MECHANISM IF LEFT UNCHECKED. TO ENSURE THE CLEANLINESS IS NOT AT ISSUE, THE LOCAL ARJOHUNTLEIGH REP IS SUPPORTING THE CUSTOMER IN DEVELOPING GOOD HOUSEKEEPING PRACTICES IN REGARD TO THE CLEANING OF THE BEDS. IN SUMMARY, THE DEVICE WAS BEING USED AT THE TIME OF THE EVENT, IT FAILED TO MEET ITS SPECS AS IT SUFFERED A MALFUNCTION AS PER THE WITNESS STATEMENT I.E. DURING WASHING THE PT WAS ROLLED ON HIS SIDE AGAINST THE ONE SIDE RAIL COLLAPSED ALLOWING THE PT TO FALL ONTO THE FLOOR. THEREFORE IT CONTRIBUTED TO THE OUTCOME OF THE EVENT. THE MOSTLY LIKELY CAUSE IS THAT THE SIDE RAIL PANEL WAS ONLY PARTIALLY RAISED AND NOT LOCKED IN THE RAISED POSITION. WE DO ADVISE 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." THE ENTERPRISE BED WAS LAUNCHED IN 2006 AND WE HAVE SOLD APPROX 33, 000 BEDS WORLDWIDE OF THIS TYPE OF MODEL FITTED WITH SPLIT SAFETY SIDES. WE HAVE REVIEWED OUR POST MARKET SURVEILLANCE AND THIS IS THE SIXTH SIMILAR INCIDENT OF THIS NATURE AND THE THIRD AT THIS FACILITY THAT WE HAVE RECORDED THIS REPRESENTS A FAILURE RATE OF 0.018%. WE DO NOT BELIEVE THAT WE HAVE AN ADVERSE TREND IN REGARD TO THIS ISSUE AS THEY APPEAR ISOLATED IN NATURE AND ALSO THE RESULT OF USE ERROR. WE SHALL CONTINUE TO MONITOR FOR ANY FURTHER COMPLAINTS OF THIS NATURE TO DETERMINE TRENDING. OTHER THAN THE ACTIONS ALREADY TAKEN WE DO NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405594 ENTERPRISE 9000 FNL ARJOHUNTLEIGH POLSKA SP. Z.O.O. ENT9000

    Patients

    Seq Age Sex Outcome Treatment
    1