MAUDE Adverse Event Report: HILL-ROM CARY NAVICARE NURSE CALL

Model Number	NNC 3.6.600
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hill-rom investigation determined the patient room was offline at the time of the reported event.The appropriate system alerts were present on the system in the room and at the nurse¿s station indicating the room was offline.A review of the log files indicates a nurse was present in the room for 1 1/2 minutes prior to pulling the code blue lever with two additional staff members entering the room prior to pulling the code blue lever.The staff remained in the room at the time the device did not ring remotely at the primary nurse station.Hill-rom requested the return of the room control board for investigation.The user facility declined to release the room control board.Investigation to date indicates the control board for the room as the potential cause of the room dropping off line.If additional information becomes available during our investigation, a follow up report will be filed.
Event or Problem Description
Hill-rom received a report from the account stating the code blue lever was pulled but that the call was delayed in ringing at the primary nurse station.

• Brand Name: NAVICARE NURSE CALL
• Common Device Name: NAVICARE NURSE CALL
• Manufacturer (Section D): HILL-ROM CARY; 1225 crescent green dr., suite 300; cary NC 27518
• MDR Report Key: 7073275
• Report Number: 2027454-2017-00001
• Device Sequence Number: 1109446
• Product Code: ILQ
• UDI-Device Identifier: 00887761001541
• UDI-Public: 00887761001541
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Nurse
• Device Model Number: NNC 3.6.600
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2017
• Initial Report FDA Received Date: 11/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 78 YR
• Patient Weight: 79