NAVICARE? NURSE CALL SYSTEMS GRS-5

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-18 for NAVICARE? NURSE CALL SYSTEMS GRS-5 manufactured by Hill-rom, Inc..

Event Text Entries

[179745306] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9719946
• MDR Report Key: 9719946
• Date Received: 2020-02-18
• Date of Report: 2015-10-21
• Date of Event: 2015-09-22
• Report Date: 2020-02-04
• Date Reported to FDA: 2020-02-04
• Date Reported to Mfgr: 2020-02-18
• Date Added to Maude: 2020-02-18
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: NAVICARE? NURSE CALL SYSTEMS
• Generic Name: SYSTEM, COMMUNICATION, POWERED
• Product Code: ILQ
• Date Received: 2020-02-18
• Model Number: GRS-5
• Device Availability: Y
• Device Age: 1 YR
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: HILL-ROM, INC.
• Manufacturer Address: 1225 CRESCENT GREEN DR. SUITE 300 CARY NC 27518 US 27518

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-02-18