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

Model Number CNS-6201A

Device Problems Electrical /Electronic Property Problem (1198); Loss of Power (1475); Complete Loss of Power (4015)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/22/2019

Event Type  malfunction  

Manufacturer Narrative

The nurse reported that the central nurse's station (cns) lost power and when it came back up the screens were not displayed as they were before.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

The nurse reported that the central nurse's station (cns) lost power and when it came back up the screens were not displayed as they were before.

Event Description

The nurse reported that the central nurse's station (cns) lost power and when it came back up the screens were not displayed as they were before.

Manufacturer Narrative

Details of complaint: incident aware date: (b)(6) 2019.The customer reported an incident regarding a cns (central nursing station) model pu-621ra, software version 02-10.This device lost power while monitoring patients.When it came back up, the screens were not displayed as they were before.The supporting ups (uninterruptable power supply) was due for pm (preventive maintenance) this month to replace the batteries, but it went out before the biomed get a chance to change them.The cns lost power and shut down.Once the ups batteries were replaced, the monitoring system started working.When the cns came up, only the secondary display had signal.During troubleshooting, the biomed found that the second display was in fact just a repeating monitor for the primary display.Also found that the dvi (digital visual interface) port was being split between the two monitors.There was also an hdmi (high definition multimedia interface) cable running from the back of the cpu (central processing unit) up to the second repeater monitor.To resolve the issue the biomed shut down the cns and removed the hdmi cable.When the unit came back up, it had a display resolution to the correct 1280 x 1024 resolution.Both displays came right up.Kept the hdmi cable removed since both the monitors were getting good power and display.No further issues reported at the time.Service requested: troubleshooting.Service performed: troubleshooting and fix.Investigation summary: the root cause of this issue is determined to be improper ups preventive maintenance by the customer and using the device off-label.The overall risk rating is medium.The nature of the complaint is user error.

• 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: 8697150
• MDR Text Key: 148030259
• Report Number: 8030229-2019-00221
• 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: 06/13/2019,11/04/2020

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: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/13/2019
• Distributor Facility Aware Date: 05/22/2019
• Device Age: 74 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/13/2019
• Initial Date Manufacturer Received: 05/22/2019
• Initial Date FDA Received: 06/13/2019
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1