BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE 8000

    MDR report key: 3192611 · Received June 6, 2013

    Report

    Report Number
    3003984900-2013-00002
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Manufacturer
    ARJOHUNTLEIGH MEDICAL BEDS DIVISION
    Product Code
    FNL
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH ON BEHALF OF THE MFR ARJOHUNTLEIGH, A BRANCH OF ARJO (B)(4). OUR ENGINEER VISITED SITE: THE PATIENT WAS STILL ON BED AT THEATRES OUR ENGINEER ASKED FOR THE BED TO BE IMMEDIATELY QUARANTINED PENDING INVESTIGATION, WARD STAFF AGREED TO LOCK THE BED IN THEIR STORE CUPBOARD OVERNIGHT WHEN IT RETURNED TO WARD TO ALLOW US TO COLLET, BED WAS TAKEN DIRECTLY TO ON SITE BED STORE FOR INITIAL FUNCTION CHECK, ALL CONTROLS (EACH SEPARATE HAND CONTROL AND PANEL) WERE CHECKED AND THE BED IS FUNCTIONING CORRECTLY, ALSO CHECKED LOCK OUT FACILITY AND AGAIN ESTABLISHED THAT ALL CONTROLS WERE CORRECTLY LOCKED, WIRING WAS ALSO CHECKED TO THE COTSIDES NO OBVIOUS PROBLEMS FOUND. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252218 ENTERPRISE 8000 MEDICAL BED FNL ARJOHUNTLEIGH MEDICAL BEDS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1