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

Model Number NNC

Device Problems Use of Device Problem (1670); Application Program Version or Upgrade Problem (2881); Human-Device Interface Problem (2949)

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

Event Date 07/07/2022

Event Type  Injury  

Event Description

Hillrom completed a software upgrade to the nurse call system, nnc to a new version.Hillrom upgrade team stated that no end user changes and it was just "back end" upgrades and upgrade to the naming from hillrom to volt changes.After upgrade occurred we found that medical professional do see differences.Unattended/attended modes changed to call forwarding on/off hillrom upgrade team was unaware that this would happen and sent us out the rev documentation for the upgrade.Upon reviewing the documentation, the medical staff will see the difference between how they interact with the system.Messaging went out to the staff to let them know from hospital professional.Another issue was after the upgrade was complete a device error was happening w/in our psyc building, hillrom staff was unable to figure that out and said it was a hardware issue.Hillrom staff did not respond after escalating to the project manager, then hillrom leadership said they believed it to be hardware and to call tech support.After software upgrades, part of the agreement is that the complete system is tested and end devices are replaced.This one area they would not do that.Hospital staff was notified that one room would need extra monitoring, staff communicated the attending that it would not be up until monday.Hillrom tech support contacted us on monday after the weekend and found the issue was configuration would not apply, they cleared the config and it worked.Total days from issue to completion was 4 days.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: 15067131
• MDR Text Key: 296325592
• Report Number: MW5110981
• 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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NNC
• Device Catalogue Number: NNC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1