BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE 8000

    MDR report key: 2111012 · Received April 14, 2011

    Report

    Report Number
    3003984900-2011-00009
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 23, 2011
    Manufacturer
    ARJOHUNTLEIGH MEDICAL BEDS DIVISION
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION WILL BE PROVIDED PENDING THE CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY AN OVERSEAS ARJOHUNTLEIGH REP THAT THE BED WAS IN THE GENERAL WARD WITH A PATIENT ON IT (NOT IN OPERATING USE AT THE TIME), WHEN IT STARTED MOVING UP AND DOWN ON ITS OWN. AS THE BED WAS IN THE GENERAL WARD, THE PATIENT WAS SHIFTED TO ANOTHER BED IMMEDIATELY WITHOUT ANY KIND OF INJURY OR HEALTH PROBLEM. LATER WHEN NOT IN USE AND INSPECTED BY THE FACILITY'S ENGINEER, THE BACKREST MOVEMENT WAS ALSO OPERATING INWARDS UNCOMMANDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERPRISE 8000 MEDICAL BED FNL ARJOHUNTLEIGH MEDICAL BEDS DIVISION ENT8000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other