MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CNS-6801A; CENTRAL MONITOR SYSTEM

Model Number CNS-6801A

Device Problems No Display/Image (1183); Display or Visual Feedback Problem (1184); Power Problem (3010)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2022

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) is rebooting and will not go to the windows display after a power outage at the facility.No patients were harmed.The bme did a hard reboot, and the cns gave a monitor network disconnect error and when the bme connected the ethernet and manually launched the cns, the cns rebooted itself again.The bme swapped the hard drives between port 1 and port 2 but the cns is still rebooting and did not go into the windows display.The bme requested to send the cns into nihon kohden for service.A loaner was sent to the customer.

Manufacturer Narrative

The biomedical engineer (bme) reported that the central nurse's station (cns) is rebooting and will not go to the windows display after a power outage at the facility.No patients were harmed.The bme did a hard reboot, and the cns gave a monitor network disconnect error and when the bme connected the ethernet and manually launched the cns, the cns rebooted itself again.The bme swapped the hard drives between port 1 and port 2 but the cns is still rebooting and did not go into the windows display.The bme requested to send the cns into nihon kohden for service.A loaner was sent to the customer.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 when additional information becomes available.Attempt #1: 12/05/2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2: 12/09/2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3: 12/13/2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the central nurse's station (cns) is rebooting and will not go to the windows display after a power outage at the facility.No patients were harmed.The bme did a hard reboot, and the cns gave a monitor network disconnect error and when the bme connected the ethernet and manually launched the cns, the cns rebooted itself again.The bme swapped the hard drives between port 1 and port 2 but the cns is still rebooting and did not go into the windows display.The bme requested to send the cns into nihon kohden for service.A loaner was sent to the customer.Service performed: nihon kohden repair department (nkrd) received the customer's unit and the reported problem of " cns rebooting was duplicated upon testing".Nkrd received 2 hdd's with the customer's cns and re-imaged both hdd's with software version 02-10 and activated 32 beds.Rebooted the pu-681ra and issue is resolved.Device was tested per the operators/service manual and was returned to the customer in good working condition.Investigation summary: causes of hard drive failures include normal hard drive failure or failure resulting from frequent power loss, inappropriate shutdown/reboot procedure.The operator manual outlines specific steps to perform a device shutdown or reboot.As with any device, the hard drive supplied with the cns has limited durability.It is the manufacturer's recommendation to have hard drives replaced every two years or 20,000 hours of use.As a maintenance reminder, user is prompted with a message on the bottom right of the cns screen to check hard drive status once usage has reached 20,000 hours.Review of the serial number history shows the device had been in service since 2019 and no recurrence of the reported issue.

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) is rebooting and will not go to the windows display after a power outage at the facility.No patients were harmed.The bme did a hard reboot, and the cns gave a monitor network disconnect error and when the bme connected the ethernet and manually launched the cns, the cns rebooted itself again.The bme swapped the hard drives between port 1 and port 2 but the cns is still rebooting and did not go into the windows display.The bme requested to send the cns into nihon kohden for service.A loaner was sent to the customer.

• Brand Name: CNS-6801A
• Type of Device: CENTRAL MONITOR SYSTEM
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; attn: shama mooman; 1-1 tajino; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 15974388
• MDR Text Key: 308239556
• Report Number: 8030229-2022-03236
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921131640
• UDI-Public: 04931921131640
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/22/2023

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-6801A
• Device Catalogue Number: PU-681RA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2022
• Initial Date FDA Received: 12/13/2022
• Supplement Dates Manufacturer Received: 01/23/2023
• Supplement Dates FDA Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1