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	07/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Baxter received a report stating the nurse call installation bed exit alarms were not alerting to nurse station intermittently.The process step during which this occurred was unknown.There was no patient injury or death reported with this event.
Additional Manufacturer Narrative
Baxter has contacted the account three times for inspection and troubleshooting.The account was unresponsive to the attempts, therefore, baxter is completing this complaint due to the amount of time.If additional relevant information is received it will be submitted in a supplemental report.Based on this information, no further action is required.Although there was no reported injury with this event, if the report of bed exit alarms not alerting were to recur, it could potentially cause serious injury or death.Therefore baxter is reporting 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: 50183169
• Report Number: 2027454-2026-00118
• Device Sequence Number: 15922856
• Product Code: ILQ
• UDI-Device Identifier: 00887761995079
• UDI-Public: (01)00887761995079
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/07/2026

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
• 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: 07/11/2026
• Initial Report FDA Received Date: 08/07/2026
• 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