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	05/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The voalte nurse call system provides a comprehensive communication and information system that places patient calls, staff calls as well as emergency and code calls.The system provides an annunciation of these calls at both room locations and primary(dedicated) nurse call stations.The voalte nurse call system also has an option for secondary notification calls to customers provided third-party products (e.G cell phones) where calls may also be forwarded.The secondary notification workflows are options offered to the facilities that the facility may or may not choose to implement as an add on to their primary notifications, depending on their facility¿s design and needs.The nurse call system secondary notification provides visual and/or audible event alert notification via customer designated nurse call communication devices.The location of these devices can be at a specific console in pbx department, a staff station located in a break room or hallway, mobile phones, etc.The customer preference/request at the time of the initial integration.The baxter technician thoroughly inspected the nurse call device and was unable to duplicate the reported issue.The nurse call device functioned as designed.However, if the reported event of a code blue not alerting were to recur, it would be likely to cause or contribute to death or serious injury, therefore baxter considers this event reportable.
Event or Problem Description
A customer contacted technical service to report that nurse call servercode calls were not alerting at primary console.There were no other devices reported to be involved.The reporter did not communicate this event to another baxter department or authority.

• 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: 25515068
• Report Number: 2027454-2026-00082
• Device Sequence Number: 21461635
• Product Code: ILQ
• UDI-Device Identifier: 00887761995079
• UDI-Public: (01)00887761995079
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/16/2026

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: P2599NNCSERVER
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 06/16/2026
• 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