BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE 9000

    MDR report key: 3234015 · Received July 11, 2013

    Report

    Report Number
    3007420694-2013-00034
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. ZO.O.
    Product Code
    FNL
    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). IT HAS BEEN REPORTED BY THE CUSTOMER THAT THE MECHANICAL CPR WAS NOT WORKING. THERE WERE NO CONSEQUENCES FOR THE PT - NO INJURY. ARJOHUNTLEIGH HAS BEEN PROVIDED WITH A PHOTO SHOWING THAT ONE OF THE EYELETS AT THE END OF CPR CABLE BEEN PULLED OFF. ALTHOUGH THE BED IS ALSO FITTED WITH AN ELECTRICAL CPR FUNCTION AND THERE IS NO SUGGESTION THAT THERE HAD BEEN AN ELECTRICAL FAILURE OF THIS FUNCTION. THE REASON FOR RAISING THE MDR IS THE MECHANICAL FAILURE OF THE EMERGENCY CPR RELEASE WHICH IS INTENDED AS AN ALTERNATIVE IN THE CASE OF AN ELECTRICAL FAILURE. IN SUMMARY, THE DEVICE FAILED TO MEET SPECIFICATIONS, WAS BEING USED AT THE TIME OF THE EVENT AND THEREFORE, PLAYED A ROLE IN THE EVENT, HOWEVER, NO INJURIES WERE SUSTAINED. THE ENTERPRISE 5000, 8000 AND 9000 RANGE OF BEDS USE THE SAME BOWDEN CABLE FOR THE MECHANICAL CPR WHICH HAS BEEN DUAL SOURCED SINCE 2008, AFTER RECEIVING THE COMPLAINT WE WERE ABLE TO IDENTIFY SUPPLIER 'B' OF THESE PARTICULAR CPR CABLES AND AS A PRECAUTIONARY MEASURE USE OF THE CABLES FROM THIS SUPPLIER WERE SUSPENDED PENDING FURTHER INVESTIGATION. (B)(4). THE DHR'S FOR THE BED INVOLVED HAVE BEEN REVIEWED; NO ANOMALIES WERE RECORDED ON THE RECORD AT THE TIME OF MFR, ONE OF THE REQUIREMENTS OF THE WORK INSTRUCTIONS AND QUALITY PROCEDURES FOR THE DEVICES IS A 100% FUNCTIONALITY TEST OF THE MECHANICAL CPR FEATURE BEFORE THEY ARE CLEARED FOR DISPATCH. FURTHER INVESTIGATION AND RE-TESTING OF THE BOWDEN CABLES FROM BOTH SUPPLIERS HAS BEEN UNDERTAKEN AND WHILST BOTH OF THE SUPPLIERS CPR CABLES PASSED THE TENSILE TESTS REQUIREMENTS FOR SECURITY OF THE BALL AND EYELET ATTACHMENTS. IT WAS NOTED THAT SUPPLIER 'B' CPR CABLES HAD SIGNIFICANTLY LOWER RESULTS ON THE SECURITY OF THE EYELET THAN SUPPLIER 'A'. AS A CONSEQUENCE OF THIS SUPPLIER 'B' HAS BEEN REMOVED FROM OUR APPROVED SUPPLIER LIST DUE TO THE CRITICAL PERFORMANCE CRITERIA OF THE CABLES. WE HAVE CONTINUED TO MONITOR FOR ANY FURTHER INCIDENTS OF THIS NATURE AND WE HAVEN'T SEEN ANY NEW FAILURES. THEREFORE THE FAILURE RELATING TO THIS ISSUE IS LESS THAN 0.01%, WE SHALL CONTINUE TO MONITOR FOR ANY FURTHER INCIDENTS OF THIS NATURE. HOWEVER, GIVEN THE CIRCUMSTANCES AND THE NUMBER OF PRODUCTS IN THE MARKET THIS INCIDENT APPEARS TO BE ISOLATED ISSUE OTHER THAN THE ACTION 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
    320831 ENTERPRISE 9000 FNL ARJOHUNTLEIGH POLSKA SP. ZO.O.

    Patients

    Seq Age Sex Outcome Treatment
    1