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

Model Number CNS-6201A

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 02/22/2024

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the central nurse's station (cns) was shutting down and re loading intermittently while in patient use.The bme reported they were not getting any hard disc drive (hdd) port failure messages when this occurs.No patient harm was reported.Bme requested nihon kohden to send them two new hard disc drives (hdd) to replace in this cns.The bme received the hard disc drives (hdds) and replaced them in the cns but the same rebooting issue was occuring with the new hdd's too.The drives will boot into windows, show the desktop, and then it will automatically reboot itself again.Technical support advised the bme that since this is occurring with new hdd's, it does not seem to be the hard disc drives related and could be another board or component inside the cns failing.Nihon kohden technician recommended to the bme to return this cns for an exchange unit.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.The following fields contain no information (ni), as attempts to obtain the information were made, but not provided: attempt # 1: 02/27/2024 emailed the customer via microsoft outlook for all information in the ni list above: reply was received from bme who stated " there was 1 patient that was on temporary blood pressure(bp) monitoring from a wireless bsm- i do not have their name or any further information".

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) was shutting down and re loading intermittently while in patient use.The bme reported they were not getting any hard disc drive (hdd) port failure messages when this occurs.No patient harm was reported.Bme requested nihon kohden to send them two new hard disc drives (hdd) to replace in this cns.The bme received the hard disc drives (hdds) and replaced them in the cns but the same rebooting issue was occuring with the new hdd's too.The drives will boot into windows, show the desktop, and then it will automatically reboot itself again.Technical support advised the bme that since this is occurring with new hdd's, it does not seem to be the hard disc drives related and could be another board or component inside the cns failing.Nihon kohden technician recommended to the bme to return this cns for an exchange unit.

Manufacturer Narrative

Incident summary/troubleshooting/results: on (b)(6) 2024, the biomed reported that this central nurse's station (cns) (model: pu-621ra, serial number (b)(6) application would shut down and come back up intermittently.The biomed stated thew were not getting any hdd port failure error messages, the unit would just shut down.The customer decided to move forward with purchasing new hdds to resolve the issue.Two brand new hdds were sent to the customer, however; the customer's cns began the same reported issue of the unit rebooting itself.The customer stated the drives would boot into windows, show the desktop, and then it would automatically reboot itself again.Nk technical support informed the customer that the issue is not hdd related and most likely caused by an internal board or component that is failing.The customer stated they would replace the cns with a newer to resolve the issue.There was patient involvement when the issue occurred, but no report of patient harm, no injury, nor any adverse event, due to the reported issue.Root cause analysis: we were able to confirm the reported issue.Although a definitive root cause could not be determined.Based on the available information, the most probable root cause of the device rebooting itself was due to internal board failure or component failure.This could have been caused by normal wear and tear, overheating or component degradation.The customer stated they would be getting a newer cns to replace this one to resolve the issue.Device history: a serial number review of the reported device (model: pu-621ra, serial number (b)(6) does not reveal additional related complaints.Complaint history review of the customer's account does not reveal trends for similar complaints.This device has expired its warranty period.

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) was shutting down and re loading intermittently while in patient use.The bme reported they were not getting any hard disc drive (hdd) port failure messages when this occurs.No patient harm was reported.Bme requested nihon kohden to send them two new hard disc drives (hdd) to replace in this cns.The bme received the hard disc drives (hdds) and replaced them in the cns but the same rebooting issue was occuring with the new hdd's too.The drives will boot into windows, show the desktop, and then it will automatically reboot itself again.Technical support advised the bme that since this is occurring with new hdd's, it does not seem to be the hard disc drives related and could be another board or component inside the cns failing.Nihon kohden technician recommended to the bme to return this cns for an exchange unit.

• Brand Name: CNS-6201A
• 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; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 18918668
• MDR Text Key: 337854911
• Report Number: 8030229-2024-04185
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921114131
• UDI-Public: 04931921114131
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/17/2024

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2024
• Initial Date FDA Received: 03/15/2024
• Supplement Dates Manufacturer Received: 05/16/2024
• Supplement Dates FDA Received: 05/17/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/21/2017
• 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: BSM; BSM