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

Model Number CNS-6201A

Device Problems Image Display Error/Artifact (1304); Output Problem (3005)

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

Event Date 09/13/2020

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the central nurse's station (cns) shut down due to a power outage at the hospital.Upon bootup, the cns showed a "monitor network service disconnect" error message.During troubleshooting the customer later reported they also got a "hdd port 1 error" message.No patient harm was reported.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 central nurse's station (cns) shut down due to a power outage at the hospital.Upon bootup, the cns showed a "monitor network service disconnect" error message.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the customer reported that this central nurse's station (cns) was shut down because of a power outage at the hospital.Upon booting up, the cns has a "monitor network service disconnected" error message.The cns was being used to monitor patients at the time of the incident.Upon further troubleshooting, the customer determined the device experienced a hard drive failure.Service requested/performed: troubleshooting.Investigation summary: when a cns is unexpectedly shut down during operation, without going through the proper shutdown sequence, it could cause a hard drive failure.There was a power outage at the facility.One of the raid hard drives failed due to the improper shutdown sequence, as a direct result of the power outage.This is an environmental issue.The device is designed with a redundant array of two hard disks.When one hard disk fails, the other can take over.The manufacturer provided all sites with ".Bat" file patch which helps recognize hard disk failure and provides a warning message when a hard drive begins to fail.The manufacturer also updated device manufacturing process to incorporate the ".Bat" file function.Labeling and operator's manual for various generations of this device recommend periodic maintenance or replacement of hard disk drives.There is low likelihood of risks associated with the use of defective device.In order for the hard disk drive to cause adverse health consequences, an improbable sequence of user error and other events would all need to occur: 1) user declined to permit installation of software patch; 2) user fails to respond to warning alerts that one of two hard drives has failed; 3) user failed to perform periodic testing and maintenance of hard drive; 4) critically ill patient sustains sudden deterioration simultaneously as the occurrence of a failure of the second (redundant) hard drive; 5) caregivers are unaware of triggering of alarms on bedside monitors or have delayed awareness.The risk level is determined to be medium.

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) shut down due to a power outage at the hospital.Upon bootup, the cns showed a "monitor network service disconnect" error message.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the customer reported that this central nurse's station (cns) was shut down because of a power outage at the hospital.Upon booting up, the cns has a "monitor network service disconnected" error message.The cns was being used to monitor patients at the time of the incident.Upon further troubleshooting, the customer determined the device experienced a hard drive failure.Service requested/performed: troubleshooting.Investigation summary: when a cns is unexpectedly shut down during operation, without going through the proper shutdown sequence, it could cause a hard drive failure.There was a power outage at the facility.One of the raid hard drives failed due to the improper shutdown sequence, as a direct result of the power outage.This is an environmental issue.The device is designed with a redundant array of two hard disks.When one hard disk fails, the other can take over.The manufacturer provided all sites with ".Bat" file patch which helps recognize hard disk failure and provides a warning message when a hard drive begins to fail.The manufacturer also updated device manufacturing process to incorporate the ".Bat" file function.Labeling and operator's manual for various generations of this device recommend periodic maintenance or replacement of hard disk drives.There is low likelihood of risks associated with the use of defective device.In order for the hard disk drive to cause adverse health consequences, an improbable sequence of user error and other events would all need to occur: 1) user declined to permit installation of software patch; 2) user fails to respond to warning alerts that one of two hard drives has failed; 3) user failed to perform periodic testing and maintenance of hard drive; 4) critically ill patient sustains sudden deterioration simultaneously as the occurrence of a failure of the second (redundant) hard drive; 5) caregivers are unaware of triggering of alarms on bedside monitors or have delayed awareness.The risk level is determined to be medium.The following fields contain no information (ni), as attempts to obtain information were made, but not provided.Corrected information: b4 date of this report: corrected the date from 04/05/2021 to 05/05/2021.

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) shut down due to a power outage at the hospital.Upon bootup, the cns showed a "monitor network service disconnect" error message.No patient harm was reported.

• Brand Name: CNS-6201A
• Type of Device: CENTRAL MONITOR SYSTEM
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia; attn: shama mooman; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• MDR Report Key: 10646285
• MDR Text Key: 212517089
• Report Number: 8030229-2020-00591
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921114131
• UDI-Public: 04931921114131
• 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,Followup
• Report Date: 05/05/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/13/2020
• Initial Date FDA Received: 10/07/2020
• Supplement Dates Manufacturer Received: 04/28/2021; 04/28/2021
• Supplement Dates FDA Received: 05/05/2021; 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1