MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CNS-6201A; CENTRAL MONITOR SYSTEM

Model Number CNS-6201A

Device Problems Loss of Power (1475); Human Factors Issue (2948)

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

Event Date 02/08/2018

Event Type  malfunction  

Manufacturer Narrative

The nurse reported that the central nurse's station (cns) shut down after the uninterrupted power supply (ups) was bumped.The cns was giving a "network service disconnect" error message upon restart.While troubleshooting, the raid had been rebuilding on its own.The nurse restarted the device once the raid rebuild was complete and the system was working normally again.No patient harm was reported.

Event Description

The nurse reported that the central nurse's station (cns) shut down after the uninterrupted power supply (ups) was bumped.The cns was giving a "network service disconnect" error message upon restart.

Manufacturer Narrative

H10: additional narrative: on (b)(6) 2018, (b)(6) reported she accidentally hit the ups with her foot and it restarted the cns-6201a (pu-621ra sn:(b)(6) ).The cns came back up with an error message on the windows screen "network service disconnect".Service requested troubleshooting/assistance.Service performed customer was advised to check the network cable connections, and both ends were plugged in.The network activity lights on the back of the cns were lit up.The network status said connected in the control panel.There was a cable lock on the cns to prevent the cable from being unplugged.The nurse was able to find a screwdriver and removed the cable lock.The nurse said the cable seemed loose and did not make the click when plugged into the cns.Raid was also rebuilding on its own during troubleshooting.After it finished, nurse was instructed to restart the device through windows, and upon rebooting, the cns patient monitoring software came back up.The system was functioning normally.Investigation result the device was put into service on 12/23/16, which is over 1.5 years prior to the reported issue.The root cause is determined to be user error.The ups connected to the cns was inadvertently kicked, causing the cns to restart.This improper restart led to degradation of raid and the "network disconnect error".Issue was resolved after raid rebuild was complete.No part was replaced during this process.Based on the given information, this issue is not suspected to be caused by deficient device or design.Corrected information: g4.Date received by manufacturer: should be 02/08/2018 not 03/08/2018 as listed on mdr initial report d11& c2 concomitant medical products: ups was used in conjunction with the cns.

Event Description

The nurse reported that the central nurse's station (cns) shut down after the uninterrupted power supply (ups) was bumped.The cns was giving a "network service disconnect" error message upon restart.

• Brand Name: CNS-6201A
• Type of Device: CENTRAL MONITOR SYSTEM
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 161-8 560; JA 161-8560
• MDR Report Key: 7325309
• MDR Text Key: 101982667
• Report Number: 8030229-2018-00061
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921114131
• UDI-Public: 4931921114131
• Combination Product (y/n): N
• PMA/PMN Number: K102376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 07/10/2019

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
• Device Operator: Health Professional
• Device Model Number: CNS-6201A
• Device Catalogue Number: PU-621RA
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/10/2019
• Distributor Facility Aware Date: 07/10/2019
• Device Age: 24 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/10/2019
• Initial Date Manufacturer Received: 03/08/2018
• Initial Date FDA Received: 03/08/2018
• Supplement Dates Manufacturer Received: 07/10/2019
• Supplement Dates FDA Received: 07/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1
• Treatment: UPS