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

Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2023
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 were performed by baxter and the reported problem was resolved by replacing the audio station bed connector (asbc).In this event, the customer reported the bed exit alarms were not annunciating at the nurse¿s station and a patient fell; however, the patient was not injured.There was no report of medical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, which concludes a serious injury did not occur in this case.If a bed exit call not annunciating at the nurse¿s station (primary location) were to recur, it would be likely to cause or contribute to a death or serious injury.
Event or Problem Description
The customer reported the bed alarms were not routing to the nurse's station.A patient fall occurred but there was no injury to the patient.This report was filed in our complaint handling system as complaint # (b)(4).

• 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: 17826431
• Report Number: 2027454-2023-00081
• Device Sequence Number: 12302401
• 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): 09/27/2023

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
• 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: 09/05/2023
• Initial Report FDA Received Date: 09/27/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown