MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CNS-9700A; CENTRAL MONITOR SYSTEM

Model Number CNS-9700A

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

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

Event Date 09/22/2020

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the central nurse's station (cns) was giving a "system failure" error message on 3 tiles at the cns.Nk ts advised them to reboot the affected bedsides, which resolved the issue.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.Additional device information: concomitant medical device: the following device was used in conjunction with the cns: bsms: model #: ni, sn #: ni.

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) was giving a "system failure" error message on 3 tiles at the cns.

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) was giving a "system failure" error message on 3 tiles at the cns.

Manufacturer Narrative

The biomedical engineer (bme) reported that the central nurse's station (cns) was giving a "system failure" error message on 3 tiles at the cns.Nk ts advised them to reboot the the affected bedsides, which resolved the issue.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.

Manufacturer Narrative

Details of complaint: the customer reported that an mu-971ra unit was giving a "system failure" error message on 3 tiles at the cns.The nk ts member advised the customer to reboot the affected besides and the issue was resolved.No patient harm was reported.Service requested: troubleshooting.Service performed: troubleshooting.Investigation summary: the root cause of the issue could not be determined as the customer was unable to provide additional information.After the nk ts team assisted the customer, the issue was resolved, and the device operates to the manufacturer specifications.Although the severity was moderate given that the malfunction occurred while in patient use, the probability of the malfunction recurring is improbable.The risk assessment determined the issue poses a medium risk.Therefore, the reported issue does not require further investigation through the capa process.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the cns: bsms: model #: ni.Sn #: ni.Additional information: h10.Additional manufacturer narrative: the investigation summary was missing from fu 001.

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) was giving a "system failure" error message on 3 tiles at the cns.

• Brand Name: CNS-9700A
• 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: 10707082
• MDR Text Key: 212516250
• Report Number: 8030229-2020-00624
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921000663
• UDI-Public: 04931921000663
• Combination Product (y/n): N
• PMA/PMN Number: K023475
• 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: 03/26/2021

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-9700A
• Device Catalogue Number: MU-971RA
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/22/2020
• Initial Date FDA Received: 10/20/2020
• Supplement Dates Manufacturer Received: 03/03/2021; 03/03/2021
• Supplement Dates FDA Received: 03/27/2021; 03/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BEDSIDE MONITORS; BEDSIDE MONITORS; BEDSIDE MONITORS