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

Device Problems Application Program Problem (2880); Communication or Transmission Problem (2896); Protective Measures Problem (3015)

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

Event Date 08/17/2022

Event Type  malfunction  

Event Description

It was discovered that the new tower (150 bed tower) did not get programmed correctly to notify us when there was a system error.Vendor technician remotely programmed it, but didn't notice that there were all sorts of errors being generated.We urgently contacted them and had them de-program it, then scheduled a new time to work with the vendor and our network team to resolve the communication issues in the system.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: 15321115
• MDR Text Key: 298988682
• Report Number: MW5111777
• 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
• 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