MAUDE Adverse Event Report: HILL-ROM, INC. HILL-ROM NAVICARE NURSE CALL OR VOALTE; SYSTEM, COMMUNICATION, POWERED

Model Number NNC OR VOALTE NURSE CALL

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/11/2022

Event Type  malfunction  

Event Description

Vendor technician did work on programming bldg b6, north to combine departments.After he left, we noticed that the staff no longer had the ability to triage calls at the staff console and send an "rn request" to the assigned staff phone.We found that the programmer had changed the call type from "notification" to "patient".We changed the call type back and resolved the issue.There were several days the staff didn't have the ability to triage to an rn.A (b)(4) case number was opened ((b)(4)) by one of the hospital biomeds.It was resolved by the biomed admin and commented on the ticket.Fda safety report id# (b)(4).

• Brand Name: HILL-ROM NAVICARE NURSE CALL OR VOALTE
• Type of Device: SYSTEM, COMMUNICATION, POWERED
• Manufacturer (Section D): HILL-ROM, INC.
• MDR Report Key: 15321099
• MDR Text Key: 298984959
• Report Number: MW5111776
• Device Sequence Number: 1
• Product Code: ILQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NNC OR VOALTE NURSE CALL
• Device Catalogue Number: NNC OR VOALTE NURSE CALL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other