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 Problems Device Difficult to Program or Calibrate (1496); Application Program Problem (2880)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Hill-rom nurse call service tech (hill-rom case# (b)(4)) removed programming for code blue calls to go to the wireless phones in both a buildings.They were to be removing emergency calls from the code blue group number and program them to an emergency group number.They programmed code blue to the emergency number and this would not have gone to the code blue response team.Error was fixed later, but there was a time when code blue notification was in jeopardy.This was not noticed by the hill-rom team, but the biomed team at the hospital in which they had to test and verified that hill-rom did indeed delete the code blue numbers.Down time procedures were put in place by (b)(4) health, then after hill-rom was notified to correct the problem, the (b)(4) health biomed team tested again to verify the code blues were working again.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: 15321085
• MDR Text Key: 298988867
• Report Number: MW5111775
• Device Sequence Number: 1
• Product Code: ILQ
• Combination Product (y/n): N
• 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