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

Model Number CNS-6801A

Device Problems Display or Visual Feedback Problem (1184); Application Program Problem (2880); Appropriate Term/Code Not Available (3191); Data Problem (3196)

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

Event Date 06/11/2021

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the central nurse's stations (cns) has the issue where the system "locks up" and they can't print, admit and discharge.All review data is missing.They can still navigate the screen, but some features do not work.Live waveforms will still work, but there's nothing inside full disclosure.The staff has been hard restarting the units to correct the issue, after the restart, all normal operation and data comeback; however, the issue eventually returns after a few hours or 12-24 hours.The unit is being exchanged.There was no patient injury 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.Attempt # 1: (b)(6) 2021 emailed the customer via (b)(6) for patient information: the customer replied with the devices that were used in conjuction with the cns, but for the patient information the customer stated, i have no demographics for them.Attempt # 1: (b)(6) 2021 emailed the customer via (b)(6) for patient information: the customer replied with the devices that were used in conjuction with the cns, but for the patient information the customer stated, i have no demographics for them.Attempt # 1: (b)(6) 2021 emailed the customer via (b)(6) for patient information: the customer replied with the devices that were used in conjunction with the cns, but for the patient information the customer stated, i have no demographics for them.Additional model information: concomitant medical device: the following device was used in conjunction with the cns: bedside monitor (bsm) & gz transmitter: model #: ni, serial #: ni, device manufacturer data: ni, unique identifier (udi) #: ni, returned to nihon kohden: ni.

Event Description

The customer reported that the central nurse's station (cns) has the issue where the system "locks up" and they can't print, admit and discharge.All review data is missing; however, after the unit is restarted, all normal operation and data comeback, but the issue eventually returns.

Manufacturer Narrative

Details of complaint: the customer reported that the central nurse's station (cns) was locking up and could not print or admit and discharge patients.All review data was also missing.The device was sent in for evaluation.No patient harm or injury was reported.Investigation summary: nihon kohden repair center (nk rc) was unable to duplicate the reported issues or determine a definitive root cause of the reported issues, based on the evaluation of the device.However, based on the available information, it is possible that the issue was due to a user related error, or a network facility environmental or software issue, which can lead to the reported issue.Although we were unable to determine a definitive root cause of the issue, we have identified some potential causes of the issues where the cns device experienced multiple issues, (including app advisory error message issues, the system locking up, unable to print or perform admit or discharge, and full disclosure issues, and selections for functions being grayed out.Potential causes of the cns device experiencing multiple issues, (including the system locking up, unable to print or perform admit or discharge, and full disclosure issues, and selections for functions being grayed out) are typically due to, but are not limited to, user related setup error issues and/or software / network / connectivity / environmental / it issues, or damage to the device or its components.

Event Description

The customer reported that the central nurse's station (cns) was locking up and could not print or admit and discharge patients.All review data was also missing.

• 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: 12140245
• MDR Text Key: 260768745
• Report Number: 8030229-2021-00398
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/20/2023

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/11/2021
• Initial Date FDA Received: 07/08/2021
• Supplement Dates Manufacturer Received: 03/08/2023
• Supplement Dates FDA Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2019
• 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: BEDSIDE MONITOR (BSM); BEDSIDE MONITOR (BSM); GZ TRANSMITTER; GZ TRANSMITTER