MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION VOALTE NURSE CALL; SYSTEM, COMMUNICATION, POWERED

Model Number	P2599NNCINSTALL
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Codes	Fall (1848); Hemorrhagic Stroke (4417)
Date of Event	05/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a voalte nurse call did not alarm and a patient fell.The patient was found on the floor due to an unwitnessed fall.The patient sustained an ¿acute hemorrhage to the left frontal lobe.¿ the customer reported that the patient¿s injury ¿remained stable,¿ ¿no acute neurosurgical intervention was indicated or required,¿ and the patient was discharged to a skilled nursing facility.The bed¿s exit alarm was activated and signaling; however, the voalte nurse call did not trigger.A review of the nurse call logs shows that the associated bed was offline (not connected via communication cable) prior to and leading up to the reported event, indicating that the communication cable that connects the bed to the nurse call system was not connected at the time of the event.Additionally, the log file showed that other features of the nurse call system (staff locating) functioned as designed.Furthermore, an inspection of the associated bed performed by the facility noted the bed to be working as intended.The cause of the event can be attributed to use error (failure of the caregiver to connect the bed to the nurse call system and not due to a malfunction of the nurse call system or the associated bed).Instructions for use (ifu) state to verify that all cables to the asbc are still connected properly, staff should be instructed this can be performed by checking for a flashing bed indicator on the dome light prior to canceling a call or by visually checking the connections to the asbc.No further information was available at the time of this report.
Additional Manufacturer Narrative
H11: the event history log and nurse call logs were reviewed and showed that the associated bed was offline (not connected via communication cable) prior to and leading up to the reported event, indicating that the communication cable that connects the bed to the nurse call system was not connected at the time of the event.Additionally, the log file showed that other features of the nurse call system (staff locating) functioned as designed.Furthermore, an inspection of the associated bed performed by the facility noted the bed to be working as intended.The device instructions for use (ifu) state to verify that all cables to the asbc are still connected properly, staff should be instructed this can be performed by checking for a flashing bed indicator on the dome light prior to canceling a call or by visually checking the connections to the asbc.The cause of the event can be attributed to a user error (failure of the caregiver to connect the bed to the nurse call system and not due to a malfunction of the nurse call system or the associated bed).Should additional relevant information become available, a supplemental report will be submitted.

• 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: 22202384
• Report Number: 2027454-2025-00109
• Device Sequence Number: 18071103
• Product Code: ILQ
• UDI-Device Identifier: 00887761985209
• UDI-Public: 00887761985209
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: P2599NNCINSTALL
• Device Catalogue Number: P2599NNCINSTALL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2025
• Initial Report FDA Received Date: 06/13/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NI.
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown