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	12/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The baxter technician found the configuration was incorrect.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 arranged to get the alarm configured correctly for the customer to resolve the issue.Although there was no injury associated with this event, if the reported event were to recur it could lead to injury or death.Therefore, baxter is reporting this complaint.
Event or Problem Description
On 03-dec-2025, a customer contacted technical service to report that nurse call installation (product code p2599nncinstall, serial number (b)(6)-2nd floor-icu/or), had code call not alerting not showing in the grs10 console.The process step during which this occurred was unknown.There was no patient injury or death reported with this event.

• 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 ; 2242702068
• MDR Report Key: 23865718
• Report Number: 2027454-2025-00249
• Device Sequence Number: 17478817
• Product Code: IOQ
• UDI-Device Identifier: 00887761979017
• UDI-Public: (01)00887761979017
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 12/22/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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