MAUDE Adverse Event Report: HILL-ROM CARY COMLINX NCM; VOALTE NURSE CALL; SYSTEM, COMMUNICATION, POWERED

Model Number 3.9

Device Problem Device Alarm System (1012)

Patient Problem Insufficient Information (4580)

Event Date 02/21/2023

Event Type  malfunction  

Event Description

It was reported that a nurse call code blue on the msicu (adult & geriatric medical surgical & cardiac intensive care unit), room 2018, was received at the primary consoles (where it was displayed on room patient station, illuminated the dome and/or zone lights, and alerted at the nurse¿s station); however, it did not alert/announce at the secondary console central call display (ccd),private branch exchange (pbx), or customer operator.It was confirmed by the customer that nursing staff attended the patient code blue ¿within seconds¿ of the call being placed; however, the patient expired.Multiple follow-up attempts were made with the customer; however, they did not provide any further details on the chain of events, medical treatment provided, cause, date, & time of death, and the individual¿s medical diagnosis immediately prior to death.This event was captured under hillrom complaint ref # (b)(4).

Manufacturer Narrative

The voalte nurse call system provides a comprehensive communication and information system that places patient calls, staff calls as well as emergency and code calls.The system provides annunciation of these calls at both room locations and primary (dedicated) nurse call stations.The voalte nurse call system also has an option for secondary notifications calls to customer provided third party products (e.G., cell phones) where calls may also be forwarded.The secondary notification workflows are options offered to the facilities that the facility may or may not choose to implement as an ¿add on¿ to their primary notifications, depending on their facility¿s design and needs.The nurse call system secondary notification provides visual and/or audible event alert notification via customer-designated nurse call communication devices.The location of these devices can be at a specific location or locations within the facility such as a nurse console located on a nursing-specific unit, a nurse console in the pbx department, a staff station located in a break room or hallway, mobile phones, etc.The notification routing of calls is configured with the naming convention, and audio and /or visual displays based on the customer's preference/request at the time of initial integration.Inspection of the system by a hillrom technician during renovation and construction on the msicu unit found that the secondary console central call display (ccd) had been unchecked for the enterprise configuration tool (ect) to monitor code blue calls.The private branch exchange (pbx) was configured to receive both code blue and rapid response team (rrt) calls from the msicu.The system was tested, and proper operation was confirmed.Follow up with the hillrom technician notes the issue was reported 2/21/2023.According to the charge nurse, she recalled that the code blue calls routed to the pbx ccd on (b)(6) 2023.She is unaware if secondary protocols were put in place once they discovered the calls were not relaying to the pbx ccd.It is unknown how long msicu code blue and rrt calls were not captured at the pbx ccd.The technician can confirm, through the charge nurse, that the code blue calls were routing to the pbx on (b)(6) 2023.For this event, a system programming failure led to a code call being received only at the primary console and not at the secondary console ccd.A code blue with patient involvement and subsequent death did occur, however, the customer confirmed the nursing staff verified they received the notification and responded timely and appropriately.If the secondary console central call display (ccd) being unchecked for the electronic configuration tool (ect) to monitor code blue calls were to recur it is likely to cause or contribute to a serious injury or death.Therefore, for the reasons stated above, hillrom is cautiously reporting this event.

• Brand Name: COMLINX NCM; VOALTE NURSE CALL
• Type of Device: SYSTEM, COMMUNICATION, POWERED
• Manufacturer (Section D): HILL-ROM CARY; 1225 crescent green dr., suite 300; cary NC 27518
• Manufacturer Contact: keighley crosthwaite ; 1225 crescent green dr., suite 300; cary, NC 27518 ; 8129310130
• MDR Report Key: 16583670
• MDR Text Key: 312293046
• Report Number: 2027454-2023-00019
• Device Sequence Number: 1
• Product Code: ILQ
• UDI-Device Identifier: 00887761985209
• UDI-Public: 00887761985209
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 3.9
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1