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

Model Number	3.6
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2023
Type of Reportable Event	Malfunction
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.In addition, nnc enables the generation of reports, such as a call activity report or a caregiver location history report.Troubleshooting activities performed by hillrom found when a code blue alert was placed in icu 03, the pbx operator saw the alert, but it did not tone, and the cause was determined to be due to misconfigured notification procedures.There was no patient injury associated with the reported event.A missed code blue alert tone by the hospital pbx operator is likely to cause or contribute to a serious injury or death if it were to recur, as a manual or automated facility-wide announcement of the event and a summons for assistance to the code blue call is commonly performed by a pbx staff member.Hillrom is cautiously reporting this event.
Event or Problem Description
It was reported that code blue calls were not annunciating at the pbx operator for rooms icu 01 and icu 03 on the 2nd floor; however, the calls were annunciating locally.There was no patient injury associated with this report.This event was captured under hillrom complaint ref # (b)(4).

• Brand Name: NCM; 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: keighley crosthwaite ; 1225 crescent green dr., suite 300; cary, NC 27518 ; 8129310130
• MDR Report Key: 16442118
• Report Number: 2027454-2023-00016
• Device Sequence Number: 17600991
• Product Code: ILQ
• UDI-Device Identifier: 00887761001541
• UDI-Public: 00887761001541
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 02/27/2023

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: 3.6
• 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: 01/30/2023
• Initial Report FDA Received Date: 02/27/2023
• 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