BEUDAMED
    FDA Adverse Event Other Summary report: N

    COMLINX NCM SYSTEM

    MDR report key: 1530960 · Received October 22, 2009

    Report

    Report Number
    2027454-2009-00020
    Event Type
    Other
    Date Received
    October 22, 2009
    Date of Event
    November 18, 2008
    Report Date
    October 15, 2009
    Manufacturer
    HILL-ROM MANUFACTURING, INC., HILL-ROM IT SOLUTIONS
    Product Code
    ILQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (PURSUANT TO THE RESPONSE TO WARNING LETTER 2008-DT-04 ISSUED TO HILL-ROM ((B)(4)), HILL-ROM HAS EXTENDED ITS RETROSPECTIVE REVIEW OF EVENTS FOR REPORTABILITY TO INCLUDE THE (B)(4) FACILITY. THIS EFFORT HAS IDENTIFIED THE FOLLOWING EVENT AS A REPORTABLE EVENT. THUS, A MDR IS BEING SUBMITTED TO FULFILL REPORTING REQUIREMENTS.) INVESTIGATION OF THE SYSTEM CALL REPORTS AND STATUS REPORTS INDICATE THAT APPROX 30 MINUTES PRIOR TO THE ALLEGED PT FALL, A BED EXIT CALL WAS PLACED, THEN STAFF WAS LOCATED IN THE ROOM, AND THEN BED EXIT NOTIFICATION WAS TURNED OFF. THE BED EXIT NOTIFICATION WAS NOT TURNED BACK ON UNTIL APPROX 90 MINUTES AFTER THE PT FALL. TECHNICIAN EVALUATED AND TESTED THE SYSTEM, NO SYSTEM PROBLEMS OR MALFUNCTIONS WERE FOUND. THE TECHNICIAN WAS NOT ABLE TO REPRODUCE ANY ISSUE WHERE THE ALERTS DID NOT WORK PROPERLY OR WHERE THE BED EXIT DISABLED ITSELF AUTOMATICALLY. INVESTIGATION RESULTS SUGGESTS THIS IS A RESULT OF A USER INTERFACE ERROR IN HOW TO PROPERLY ENABLE AND DISABLE THE BED EXIT WHEN NURSING STAFF ENTER THE ROOM AND ARE TAKING A PT OUT OF BED. ADD'L CLINICAL TRAINING ON THE USE OF CARE ALERTS WAS PROVIDED.

    Description of Event or Problem · 1

    CUSTOMER INDICATED A PT EXITED THE BED AND FELL, AND THERE WAS NO BED EXIT ALERT. WHEN THIS OCCURRED THE NURSE INDICATED SHE HAD PREVIOUSLY CONFIRMED THE BED EXIT WAS ON, BUT WHEN CHECKED AFTER THE EVENT, THE BED EXIT WAS OFF, SHE STATES THIS WAS WITH NO HUMAN INTERVENTION. THE PT DID RECEIVE MINOR BRUISES AND A CUT ON FACE, BUT PT OUTCOME WAS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMLINX NCM SYSTEM COMMUNICATIONS ILQ HILL-ROM MANUFACTURING, INC., HILL-ROM IT SOLUTIONS P250001 NCM V4.0

    Patients

    Seq Age Sex Outcome Treatment
    1 NA