BEUDAMED
    FDA Adverse Event Other Summary report: N

    COMLINX NCM SYSTEM

    MDR report key: 1009090 · Received March 4, 2008

    Report

    Report Number
    2027454-2008-00001
    Event Type
    Other
    Date Received
    March 4, 2008
    Date of Event
    February 5, 2008
    Report Date
    February 9, 2008
    Manufacturer
    HILL-ROM MANUFACTURING, INC.
    Product Code
    ILQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS EVALUATED BY THE MANUFACTURER. THE SYSTEM OPERATED AS INTENDED AND NO PROBLEM WAS FOUND. AN EVALUATION OF THE SYSTEM LOG FILES DURING THE TIME IN QUESTION CONCLUDES NO SYSTEM MALFUNCTION OR UNEXPECTED ERROR WITH AUDIO CHANNELS WHICH WOULD PROHIBIT OVERHEAD PAGING. THE SEQUENCE OF THE SYSTEM EVENTS LOGGED DOES HOWEVER, SUGGEST A POTENTIAL USER ISSUE IN THAT THERE IS AN ATTEMPT TO CALL INTO THE ROOM IN QUESTION WHILE ROOM MONITORING WAS ENGAGED AND THE AUDIO CHANNEL TO THE ROOM WAS IN USE FROM THE INITIAL CALL. THE ALLEGED MALFUNCTION MAY BE ATTRIBUTED TO USER ERROR.

    Description of Event or Problem · 1

    A STAFF EMERGENCY CALL WAS PLACED. THE UNIT SECRETARY ALLEGES SHE ANSWERED THE CALL AND CONFIRMED THE INCIDENT BUT WHEN SHE ATTEMPTED TO PLACE AN OVERHEAD PAGE FOR ASSISTANCE, THE NCM SCREEN FROZE. THE USER INDICATED SHE COULD HEAR INTO THE ROOM BUT WAS NOT ABLE TO PLACE AN OVERHEAD PAGE TO ANNOUNCE THE CALL. USER VERBALLY ANNOUNCED THE CALL TO NEARBY NURSES AND CONTINUED TO PLACE ASSISTING CALLS TO OTHER DEPARTMENTS AS NEEDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA