BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVICARE NURSE CALL

    MDR report key: 7073275 · Received November 30, 2017

    Report

    Report Number
    2027454-2017-00001
    Event Type
    Malfunction
    Date Received
    November 30, 2017
    Date of Event
    October 22, 2017
    Report Date
    October 31, 2017
    Manufacturer
    HILL-ROM CARY
    Product Code
    ILQ
    UDI-DI
    00887761001541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    HILL-ROM INVESTIGATION DETERMINED THE PATIENT ROOM WAS OFFLINE AT THE TIME OF THE REPORTED EVENT. THE APPROPRIATE SYSTEM ALERTS WERE PRESENT ON THE SYSTEM IN THE ROOM AND AT THE NURSE¿S STATION INDICATING THE ROOM WAS OFFLINE. A REVIEW OF THE LOG FILES INDICATES A NURSE WAS PRESENT IN THE ROOM FOR 1 1/2 MINUTES PRIOR TO PULLING THE CODE BLUE LEVER WITH TWO ADDITIONAL STAFF MEMBERS ENTERING THE ROOM PRIOR TO PULLING THE CODE BLUE LEVER. THE STAFF REMAINED IN THE ROOM AT THE TIME THE DEVICE DID NOT RING REMOTELY AT THE PRIMARY NURSE STATION. HILL-ROM REQUESTED THE RETURN OF THE ROOM CONTROL BOARD FOR INVESTIGATION. THE USER FACILITY DECLINED TO RELEASE THE ROOM CONTROL BOARD. INVESTIGATION TO DATE INDICATES THE CONTROL BOARD FOR THE ROOM AS THE POTENTIAL CAUSE OF THE ROOM DROPPING OFF LINE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE DURING OUR INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THE CODE BLUE LEVER WAS PULLED BUT THAT THE CALL WAS DELAYED IN RINGING AT THE PRIMARY NURSE STATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852952 NAVICARE NURSE CALL NAVICARE NURSE CALL ILQ HILL-ROM CARY NNC 3.6.600 00887761001541

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death