MAUDE Adverse Event Report: HILL-ROM, INC. NAVICARE NURSE CALL; SYSTEM, COMMUNICATION, POWERED

Model Number NNC

Device Problems Inadequate User Interface (2958); Lack of Maintenance Documentation or Guidelines (2971); Wireless Communication Problem (3283); Misassembled During Installation (4049)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/14/2022

Event Type  malfunction  

Event Description

Hillrom on a new tower go-live failed to have a proper checklist to ensure a fully functioning nurse call system was properly tested and certified by their field service engineers.Issues found and corrected after hillrom indicated the system was certified: several sound and audio issues on several floors beds were not tests that they would alert through the nurse call system for patient falls.Several rooms had failed room bed connections several zone lights did not function several dome lights did not function 2 grs-10s (main nurses desks that alarms for the floor and have 2 way audio to the patient rooms) did not work.Found that several areas programmed incorrectly and not to our standard main hospital biomed staff had to test system fully to find these issues and found that many things needed to be replaced.Hillrom project teams and leadership teams could not get all of the parts and therefore were used from (b)(6) stock.Also project teams provided incorrect part numbers for some of the dome lights to ensure timely ordering.This took almost 2 full weeks to resolve and was resolved right before patients were to be seen.On go-live day, (b)(6) biomed staff noticed that no mobile phone numbers were programmed into the system, therefore no alerts would go to our mobile devices for patient care.Contacted hillrom project management staff, and while it was resolved, they stated that they weren't provided numbers to put in the system, and numbers were provided in april.Hillrom does not require their staff to provide a pre-launch or go-live check list of events that need to be done, therefore causing their staff to miss steps and having inconsistent implementation and support.Hillrom leadership has been involved and no improvements to service have been made and does not have any local staff that can support their nurse call system.They provide no full support training to biomed staff to help support their products and limited access to their nurse call system.This creates a dangerous environment in which systems can be down for days and no help for a nfpa 99 life safety code system.Fda safety report id# (b)(4).

• Brand Name: NAVICARE NURSE CALL
• Type of Device: SYSTEM, COMMUNICATION, POWERED
• Manufacturer (Section D): HILL-ROM, INC.
• MDR Report Key: 15067153
• MDR Text Key: 296375956
• Report Number: MW5110983
• Device Sequence Number: 1
• Product Code: ILQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NNC
• Device Catalogue Number: NNC
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1