MAUDE Adverse Event Report: HILL-ROM CARY NURSECALL; 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	10/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that they pushed staff assist and pulled code blue lever and pbx never got an alert.There was no patient impact or safety issues reported as a result of product performance.This incident was captured under complaint ref # (b)(4).
Additional Manufacturer Narrative
Troubleshooting determined that the console had not been configured to watch that area.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.The hrc technician reconfigured the console to resolve the issue and the system was working as designed.Based on this information, no further actions are required at this time.Although there was no injury associated with this event, if the staff assist call and code blue call were to not annunciate during an emergency it could lead to injury or death.Therefore baxter is reporting this complaint.

• Brand Name: NURSECALL
• Common Device Name: SYSTEM, COMMUNICATION, POWERED
• Manufacturer (Section D): HILL-ROM CARY; 1225 crescent green dr., suite 300; cary NC 27518
• Manufacturer Contact: keighley crosthwaite ; 1225 crescent green dr., suite 300; cary, NC 27518 ; 8129310130
• MDR Report Key: 20721948
• Report Number: 2027454-2024-00097
• Device Sequence Number: 11691204
• Product Code: ILQ
• UDI-Device Identifier: 00887761985209
• UDI-Public: 00887761985209
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/19/2024

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: 10/28/2024
• Initial Report FDA Received Date: 11/19/2024
• 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