MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION VOALTE NURSE CALL; SYSTEM, COMMUNICATION, POWERED

Model Number	P2599N
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted technical service to report that nurse call installation code calls were not annunciating.There was no patient injury or death reported with this event.
Additional Manufacturer Narrative
The investigation is ongoing,however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.
Additional Manufacturer Narrative
Product surveillance has assessed this report using the care comm device vigilance assessment document (b)(4) for arpc of code call - did not annunciate at primary location.As per the ifu 'the hospital should perform periodic testing and maintenance of the nurse call, especially code and emergency calls, to ensure the system is working properly.This should include any centralized call systems such as the central call display or code call annunciator panel.' for newly-installed rooms, verify with hospital administration that the patient room has been certified by baxter prior to room occupation by patients.This issue is solely the result of user error with no other product performance issue.User errors are not malfunctions.User errors are reported when required by the regulation - i.E., when they are associated with a reported death/serious injury or a malfunction that could result in a death/serious injury.If additional information becomes available, this report will be reassessed.

• Brand Name: VOALTE NURSE CALL
• Common Device Name: SYSTEM, COMMUNICATION, POWERED
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): RALEIGH; 1501 nowell road; ste 200; raleigh NC 27607
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242705355
• MDR Report Key: 25053991
• Report Number: 2027454-2026-00062
• Device Sequence Number: 9427199
• Product Code: ILQ
• UDI-Device Identifier: 00887761979017
• UDI-Public: (01)00887761979017
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/01/2026

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: P2599N
• Device Catalogue Number: P2599NNCINSTALL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2026
• Supplement Date Received by Manufacturer: 05/06/2026; 07/01/2026
• Initial Report FDA Received Date: 05/01/2026
• Supplement Report FDA Received Date: 06/26/2026; 07/01/2026
• 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