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

Model Number GRS-5

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/22/2015

Event Type  malfunction  

Event Description

Due to instances of failed paging our communications department conducted a study.This study and one conducted by hill-rom confirmed that the grs-5 monitor spikes at the frequency 152.0075.This is an fcc licensed frequency for medical pagin.The display gives out roughly -70db of radio frequency which is enough to interfere with paging in a 6-8ft radius based on our testing.Hill-rom was informed and did make recommendations for our testing.Spectrum analysis was done and test pages were conducted at stations with and without displays across the hospital, in a variety of environments and locations.It was found that all stations with displays in all settings interfere with the medical paging frequency.Hill-rom recommends not to use 152.0075 for paging.However, this is a licensed frequency for medical paging and our infrastructure is built to facilitate this.It is my opinion that devices should not be introduced to a medical setting which interfere with this frequency.Manufacturer response for display, hill-rom (per site reporter).Hill rom engaged in testing of their own and have shared some of the results with us.They have released a recommendation to change our frequency for paging.

• Brand Name: NAVICARE® NURSE CALL SYSTEMS
• Type of Device: SYSTEM, COMMUNICATION, POWERED
• Manufacturer (Section D): HILL-ROM, INC.; 1225 crescent green dr.; suite 300; cary NC 27518
• MDR Report Key: 9719946
• MDR Text Key: 179745306
• Report Number: 9719946
• Device Sequence Number: 1
• Product Code: ILQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/04/2020,10/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: GRS-5
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/04/2020
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1