BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE 8000

    MDR report key: 2508627 · Received March 23, 2012

    Report

    Report Number
    3003984900-2012-00014
    Event Type
    Malfunction
    Date Received
    March 23, 2012
    Date of Event
    February 24, 2012
    Report Date
    February 24, 2012
    Manufacturer
    ARJOHUNTLEIGH MEDICAL BEDS DIVISION
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH, INC. (1419652) ON BEHALF OF THE MFR ARJOHUNTLEIGH (B)(4). (B)(4).

    Description of Event or Problem · 1

    THE WHITE PLASTIC ATTACHMENTS ON THE INSIDE (BEDSIDE) OF THE SIDE RAILS ON ENTERPRISE 8000 ARE NOT VERY TIGHT RESULTING IN DIRT AND WATER COMING INTO THE HOLE. THIS HOSPITAL WARD HAS ABOUT 15 BEDS GIVING THE STAFF PROBLEMS WHEN CLEANING THE SIDE RAILS, AND THEREFORE THE WHITE ATTACHMENTS HAVE BEEN REMOVED. THE CUSTOMER CLAIMS THERE MUST BE ANY OTHER AND BETTER SOLUTION THAN THESE WHITE PLASTIC ATTACHMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERPRISE 8000 MEDICAL BED FNL ARJOHUNTLEIGH MEDICAL BEDS DIVISION 8000BD92A11BW

    Patients

    Seq Age Sex Outcome Treatment
    1 Other