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	07/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Baxter technical support contacted the account two additional times trying to obtain the resolution for this event.No response has been received from the account.Based on this information, no further action is required.
Event or Problem Description
Baxter received a report from a baxter technician stating the code/distress call was not alerting.There was no patient/user injury reported.

• 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: 22786985
• Report Number: 2027454-2025-00146
• Device Sequence Number: 20892083
• Product Code: ILQ
• UDI-Device Identifier: 00887761979017
• UDI-Public: 00887761979017
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/12/2025

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 08/12/2025
• 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