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

Model Number CNS-6801A

Device Problem Communication or Transmission Problem (2896)

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

Event Date 12/08/2021

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 nurse reported that the central nurse's station (cns) will show an error message "registered bed not ready".The wave and numeric data will disappear, patient information will disappear, and all options within the buttons in the tile will disappear.The nurse tried power cycling the cns, but some devices came back, some got "lost".No patient harm reported.Nihon kohden technician recommended that their it department reboot or restart the server and after they rebooted the server, all beds are now able to be monitored and issue is resolved.The facilities it states that they will put this server in their monthly reboot schedule.

Manufacturer Narrative

Details of complaint: the nurse reported that the central nurse's station (cns) was displaying a "registered bed not ready" error message.The waveform and numeric data, patient information, and all options within the buttons on the tile would disappear.The nurse tried power cycling the cns, but the issue persisted.Nihon kohden technical support (nk ts) recommended that their it department reboot or restart the server, which resolved the issue.No patient harm or injury was reported.Investigation summary: nk was able to confirm the reported issue was due to an it maintenance issue since the server needed to be rebooted.It was not connecting with the network and led to the reported issue of the error message and intermittent issues with patient data not being displayed properly.The issue was resolved by rebooting/restarting the server.Unfortunately, nk was unable to determine a definitive root cause as to how the it issue occurred, as the issue is user dependent, and the server is managed by the facility's it.However, since the issue was resolved by a reboot of the system, it is possible that the issue was attributed to a user related error, due to a lack of the customer performing preventative maintenance (not rebooting the device/server services), as recommended.Nk ts provided education and assistance to the customer to resolve the issue and prevent future issues.

Event Description

The nurse reported that the central nurse's station (cns) was displaying a "registered bed not ready" error message.The waveform and numeric data, patient information, and all options within the buttons on the tile would disappear.The nurse tried power cycling the cns, but the issue persisted.No patient harm reported.

• 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 ; 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: 13122466
• MDR Text Key: 285042886
• Report Number: 8030229-2021-02276
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/05/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 03/21/2023
• Supplement Dates FDA Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2020
• 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: TELEMETRY TRANSMITTER(S); TELEMETRY TRANSMITTER(S)