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

Model Number CNS-6201A

Device Problems Application Network Problem (2879); Power Problem (3010)

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

Event Date 11/19/2021

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

The biomedical engineer (bme) reported that the hospital had a power outage and as a result the central nurse's station (cns) failed to respond.The bme reports that the cns does power up, but they have a "network disconnect" message displayed on the monitor.No patient harm was reported.Nihon kohden technician asked the bme the status of the hospitals network and was informed that the hospitals network was not coming up fully which was keeping the cns from booting up properly.Nk technician requested the bme to inform nk technical support once they have a chance to confirm that the hospitals network is fully up and running but no further information on this issue has been received to date from the bme.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the hospital had a power outage and the central nurse's station (cns) failed to power back up all the way and displayed a "network disconnect" message.Technical support (ts) asked the bme the status of the hospital's network and was informed that it was not coming up fully, which was keeping the cns from booting up properly.The bme was to update ts once they confirm the network was back up but no further information has been received.No patient harm was reported.Investigation summary: as a result of the power outage, the cns abruptly lost power and shut down.Evidently, the power outage did not damage the hard drives, thus the cns was able to power back up.The "network disconnect" message pertains to the lack of a network connection.This was caused by the system-wide outage, the result of the power failure.Once power is restored to network equipment, the network connection should be restored.Since the customer did not respond to further inquiry, it is presumed that the full functionality of the cns had been restored.No malfunctioned occurred.Service history for this serial number shows this is an isolated incident.Spontaneous shutdown or spontaneous reboot events are triggered by either a power loss or a hardware failure.When the cns experiences a power loss, it can be caused by a variety of events.These events include power outages, generator tests, uninterruptable power supply (failure), power outlet failure.These are environmental factors that impact device functionality.Hardware failure that may result in spontaneous shutdown or reboot includes power cord failure, hard drive failure, and various other essential components of a computer system such as the cooling fan, internal power supply, motherboard, cpu, memory, etc.Most commonly, hard drive failures will result in spontaneous shutdown or reboot of the device.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, the 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.

Event Description

The biomedical engineer (bme) reported that the hospital had a power outage and the central nurse's station (cns) failed to power back up all the way and displayed a "network disconnect" message.

• Brand Name: CNS-6201A
• 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 ; seibu bldg 2, 4th floor 1-11-2; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 12970822
• MDR Text Key: 285190989
• Report Number: 8030229-2021-02136
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921114131
• UDI-Public: 04931921114131
• 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: 04/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2015
• 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