FDA Adverse Event Malfunction Summary report: N

NURSE CALL

MDR report key: 17700476 · Received September 7, 2023

Report

Report Number
2027454-2023-00074
Event Type
Malfunction
Date Received
September 7, 2023
Date of Event
August 15, 2023
Report Date
September 7, 2023
Manufacturer
HILL-ROM CARY
Product Code
ILQ
UDI-DI
00887761985209
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
TX, US
Reporter Occupation
OTHER

Narratives

Additional Manufacturer Narrative · 0

THE HILLROM TECHNICIAN FOUND THE CODE BLUE WAS NOT CONFIGURED FOR SOME ROOMS. THE NAVICARE® NURSE CALL¿ (NNC) SYSTEM IS A COMPREHENSIVE COMMUNICATION AND INFORMATION MANAGEMENT SYSTEM THAT HELPS CAREGIVERS PROVIDE THE BEST POSSIBLE CARE TO PATIENTS IN THE MOST EFFICIENT MANNER. THE SYSTEM FACILITATES COMMUNICATION WITHIN A NURSING UNIT. CAREGIVERS HAVE THE ABILITY TO QUICKLY LOCATE AND COMMUNICATE WITH A FELLOW STAFF MEMBER, AND PATIENTS CAN EASILY COMMUNICATE WITH CAREGIVERS, THE NURSING STATION, OR DIRECTLY TO THEIR PRIMARY CAREGIVER. THE HRC TECHNICIAN CONFIGURED PBX TO MONITOR CODE BLUE IN UNIT FOR THE CUSTOMER TO RESOLVE THE ISSUE. ALTHOUGH THERE WAS NO INJURY ASSOCIATED WITH THIS EVENT, IF THE REPORTED ISSUE WERE TO RECUR IT COULD LEAD TO INJURY OR DEATH. THEREFORE HILLROM IS REPORTING THIS COMPLAINT.

Description of Event or Problem · 0

HILLROM RECEIVED A REPORT FROM A HILLROM TECHNICIAN STATING THE CODE BLUE WAS NOT SHOWING IN THE PBX. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
925732 NURSE CALL SYSTEM, COMMUNICATION, POWERED ILQ HILL-ROM CARY 00887761985209

Patients

Seq Age Sex Outcome Treatment
1 Unknown