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

Model Number CNS-6201A

Device Problems Inappropriate Audible Prompt/Feedback (2280); Unexpected Shutdown (4019)

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

Event Date 09/16/2023

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the central nurse's station displayed technical alarms on all patients and then it shut down.The customer didn't have many details as he was not on site at the time of the call.Technical support (ts) informed the customer that with such limited information, the only thing they may be looking at is an hdd issue.Ts asked the customer for more information.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.

Event Description

The customer reported that the central nurse's station displayed technical alarms on all patients and then it shut down.There was no patient injury reported.

Event Description

The customer reported that the central nurse's station displayed technical alarms on all patients and then it shut down.There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that the central nurse's station displayed technical alarms on all patients and then it shut down.The customer didn't have many details as he was not on site at the time of the call.Technical support (ts) informed the customer that with such limited information, the only thing they may be looking at is an hdd issue.Ts asked the customer for more information.There was no patient injury reported.Investigation summary: multiple follow-up attempts were made to obtain further details but the customer could not be reached.A definitive root cause could not be determined since we could not confirm further troubleshooting or resolution details.Manufacturer references # (b)(4).Follow up 001.

• 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: 17953924
• MDR Text Key: 326178868
• Report Number: 8030229-2023-03807
• 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: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/10/2024

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: 09/16/2023
• Initial Date FDA Received: 10/17/2023
• Supplement Dates Manufacturer Received: 01/09/2024
• Supplement Dates FDA Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2021
• 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