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

Model Number CNS-6801A

Device Problems Loss of Power (1475); Communication or Transmission Problem (2896); Power Problem (3010); Wireless Communication Problem (3283)

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

Event Date 08/07/2020

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that there was a facility wide communication loss on the central nurse's stations (cnss) and the remote network stations (rnss).The customer found that the server was not powered on and checked the tripp lite ups that was connected to it and found that it was not working.They replaced it and power came back on the server.Communication was restored.They later called back and stated that the communication was restored for the cnss, but the rnss are still in communication loss.Nihon kohden computer information technology systems support made sure that the host1000 application was running.Communication loss for the rns is now resolved.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 field contains no information (ni), as attempts to obtain information were made, but not provided.

Event Description

The biomedical engineer (bme) reported that there was a facility wide communication loss on the central nurse's stations (cnss) and the remote network stations (rnss).The customer found that the server was not powered on and checked the tripp lite ups that was connected to it and found that it was not working.They replaced it and power came back on the server.Communication was restored.They later called back and stated that the communication was restored for the cnss, but the rnss are still in communication loss.Nihon kohden computer information technology systems support made sure that the host1000 application was running.Communication loss for the rns is now resolved.No patient harm was reported.

Event Description

The biomedical engineer (bme) reported that there was a facility wide communication loss on the central nurse's stations (cnss) and the remote network stations (rnss).The customer found that the server was not powered on and checked the tripp lite ups that was connected to it and found that it was not working.They replaced it and power came back on the server.Communication was restored.They later called back and stated that the communication was restored for the cnss, but the rnss are still in communication loss.Nihon kohden computer information technology systems support made sure that the host1000 application was running.Communication loss for the rns is now resolved.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that there was facility wide comm loss on the central nurse's stations (cnss) and the remote network stations (rnss).No patient harm or injury was reported.Investigation summary: the available information reasonably suggests the root cause to be power loss to the ups.Technical support (ts) advised the customer to inspect the server and switch in the closet.They noted finding the tripp lite (ups) overloaded and had since replaced it with another.The customer further explained that their local it department had installed new servers which were connected to only one ups resulting in the power loss.No response to follow up attempts suggest that the issue was resolved.Review of the history of this serial number found no recurrence of the issue.

• 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: 10498407
• MDR Text Key: 207153536
• Report Number: 8030229-2020-00514
• 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: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2020
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2018
• 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
• Treatment: REMOTE NETWORK STATIONS (RNSS); TRIPP LITE (UPS)