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

Model Number	3.6
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The navicare® nurse call¿ (nnc) system is a comprehensive communication and information management system that helps caregivers provide the best possible care to patients in the most efficient manner.The system facilitates communication within a nursing unit.Caregivers have the ability to quickly locate and communicate with a fellow staff member, and patients can easily communicate with caregivers, the nursing station, or directly to their primary caregiver.Troubleshooting activities determined the code blue switch that connects to the room control board (rcb) was not functioning and needed to be replaced.In this event, there was no patient injury or death associated with the code blue not annunciating, concluding no serious injury occurred.If the reported problem were to recur (code blue call not alerting), it would be likely to cause or contribute to a death or serious injury.
Event or Problem Description
The customer reported the code blue cord on the navicare nurse call system was pulled but the code call did not annunciate.There was no patient injury associated with this event.

• Brand Name: NURSE CALL
• Common Device Name: SYSTEM, COMMUNICATION, POWERED
• Manufacturer (Section D): HILL-ROM CARY; 1225 crescent green dr., suite 300; cary NC 27518
• Manufacturer Contact: estephania cardenas ; 1225 crescent green dr., suite 300; cary, NC 27518 ; 8129310130
• MDR Report Key: 17364634
• Report Number: 2027454-2023-00059
• Device Sequence Number: 17465318
• Product Code: ILQ
• UDI-Device Identifier: 00887761001541
• UDI-Public: 00887761001541
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 3.6
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2023
• Initial Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown