MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION Voalte Nurse Call; SYSTEM, COMMUNICATION, POWERED

Model Number	P2599
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Baxter technical support contacted the customer to provide support and resolution and was unable to duplicate the reported issue.The nurse call device functioned as designed.However, if the reported event of a bed exit call 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
Baxter received a report stating the nurse call installation bed exit alarm was not going to mobile devices or to the main 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 ; +1(224)270-5355
• MDR Report Key: 50927542
• Report Number: 2027454-2026-00142
• Device Sequence Number: 10725276
• Product Code: ILQ
• UDI-Device Identifier: 00887761979017
• UDI-Public: (01)00887761979017
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: P2599
• Device Catalogue Number: P2599NNCINSTALL
• Device Lot Number: N/A
• 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: 09/01/2026
• Initial Report FDA Received Date: 09/29/2026
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Unknown