BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE 5000

    MDR report key: 2543116 · Received April 5, 2012

    Report

    Report Number
    3003984900-2012-00017
    Event Type
    Malfunction
    Date Received
    April 5, 2012
    Date of Event
    March 9, 2012
    Report Date
    March 9, 2012
    Manufacturer
    ARJOHUNTLEIGH MEDICAL BEDS DIVISION
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH, INC. ((B)(4)) ON BEHALF OF THE MFR ARJOHUNTLEIGH MEDICAL BEDS DIVISION, MFR COMPLAINT NUMBER: (B)(4). THE COVERS THE CUSTOMER IS COMPLAINING ABOUT ARE THERE TO COVER RECESSES WHICH ARE FORMED IN THE HEAD AND FOOT BOARDS, THE HEAD AND FOOT BOARDS ARE ACTUALLY BLOW MOULDINGS AND THE RECESSES ARE FORMED TO LOCATE AND SECURE THE TWO LOCATING PEGS THAT ENABLE MOUNTING AND DEMOUNTING OF THE BOARDS TO AND FROM THE BED. THIS FEATURE IS AN INTEGRAT PART OF THE DESIGN OF THE HEAD AND FOOT BOARDS, AND THE COVER HAS BEEN USED AS MEANS COVERING THE RECESS TO ALLEVIATE POSSIBILITY OF A DIRT TRAP AND THE INGRESS OF FLUIDS INTO THE RECESS BY GIVING THE BOARD'S ONE LEVEL SURFACE. WE HAVE AN INSTALLED BASE ON THE VARIOUS MODELS OF THE ENTERPRISE BED OF APPROX 65,000 BEDS, AND FIRST WENT ONTO THE MARKET IN 2006. ADD'L INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    INGRESS OF FLUIDS IN TO THE AREA COVERED BY THE SMALL SQUARE PANELS IN THE HEAD AND FOOTBOARDS OF THE (B)(4). ISSUE DISCOVERED UPON STEAM CLEAN BY THE DOMESTIC STAFF INFECTION CONTROL RISK TO PTS AND STAFF. ISSUE DISCOVERED UPON THROUGH STEAM CLEAN BY THE DOMESTIC STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERPRISE 5000 MEDICAL BED FNL ARJOHUNTLEIGH MEDICAL BEDS DIVISION ENT5000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other