MAUDE Adverse Event Report: HILL-ROM CARY VOALTE NURSE CALL; SYSTEM, COMMUNICATION, POWERED

Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Baxter received a report from a baxter technician stating the code call was not annunciating.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).
Additional Manufacturer Narrative
The navicare® nurse call¿ (nnc) system is a comprehensive communication and information management system that helps caregivers provide the best possible care to patients in the most efficient manner.The system facilitates communication within a nursing unit.Caregivers have the ability to quickly locate and communicate with a fellow staff member, and patients can easily communicate with caregivers, the nursing station, or directly to their primary caregiver.Baxter support contacted the account two additional times trying to obtain the resolution for this alleged issue.The account confirmed they repaired the issue, but they were unable to identify what action was taken to resolve the alleged issue.¿ based on this information, no further action is required.

• Brand Name: VOALTE NURSE CALL
• Common Device Name: SYSTEM, COMMUNICATION, POWERED
• Manufacturer (Section D): HILL-ROM CARY; 1225 crescent green dr., suite 300; cary NC 27518
• Manufacturer Contact: estephania cardenas ; 1225 crescent green dr., suite 300; cary, NC 27518 ; 8129310130
• MDR Report Key: 20340659
• Report Number: 2027454-2024-00078
• Device Sequence Number: 18128910
• Product Code: ILQ
• UDI-Device Identifier: 00887761985209
• UDI-Public: 00887761985209
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/30/2024

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
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2024
• Initial Report FDA Received Date: 09/30/2024
• 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