BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE 9000

    MDR report key: 2758147 · Received August 31, 2012

    Report

    Report Number
    3007420694-2012-00029
    Event Type
    Malfunction
    Date Received
    August 31, 2012
    Date of Event
    August 1, 2012
    Report Date
    August 7, 2012
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. ZO.O.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH, INC ON BEHALF OF THE MFR ARJOHUNTLEIGH (B)(4). INITIAL INVESTIGATION HAS NOT FOUND ANY PROBLEM WITH THE PRODUCT, FURTHER INVESTIGATION WILL BE CARRIED OUT. ADD'L INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    BED MOVING WITHOUT ANYBODY TOUCHING IT. AFTER TURNING AND MAKING PT COMFORTABLE, THE BED STARTED MOVING ON IT'S OWN. THE HEAD OF THE BED MOVED FORWARD TO 45 DEGREES ANGLE AND KNEES RAISED SIMULTANEOUSLY. PT REASSURED AND TRIED TO ADJUST THE BED WHICH IT ALLOWED, BUT AGAIN IT MOVED UPWARDS, PT TRANSFERRED ONTO NEW BED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERPRISE 9000 MEDICAL BED FSA ARJOHUNTLEIGH POLSKA SP. ZO.O. ENT9000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other