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

Model Number CNS-6201A

Device Problem Loss of Power (1475)

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

Event Date 04/15/2021

Event Type  malfunction  

Manufacturer Narrative

The customer reported a blue screen and an error message stating "a problem has been detected and windows has been shut down to prevent damage to your computer.Dumping physical memory." at the central nurse's station (cns).Technical service asked the customer to reboot the cns and once the cns application completely loaded, the customer was able to view patients, issue resolved.Ts advised the customer to restart the central monitor every three months; otherwise operation becomes unstable and monitoring may stop.There was no patient injury reported.Nihon kohden continues to investigate the reported event.

Event Description

The customer reported a blue screen and an error message stating "a problem has been detected and windows has been shut down to prevent damage to your computer.Dumping physical memory." at the central nurse's station (cns).

Manufacturer Narrative

Details of complaint: the customer reported a blue screen and an error message stating "a problem has been detected and windows has been shut down to prevent damage to your computer.Dumping physical memory." at the central nurse's station (cns).Technical service asked the customer to reboot the cns and once the cns application completely loaded, the customer was able to view patients, issue resolved.Ts advised the customer to restart the central monitor every three months; otherwise operation becomes unstable and monitoring may stop.There was no patient injury reported.Investigation summary: cns crashed.Why? unstable cns software.Why? improper maintenance, not rebooting the device, periodically.The root cause of the issue was determined to be improper periodic maintenance of the device as advised in the operator's manual.Per the operator's manual, restart of the cns every three months is recommended for optimal performance of the monitor.If not done so, operation of the cns may become unstable, and monitoring may stop.The reported issue does not require further investigation through capa process since the issue was caused due to improper periodic maintenance of the deice.This does not suggest nk device deficiency/malfunction.Manufacturer references # (b)(4).

Event Description

The customer reported a blue screen and an error message stating "a problem has been detected and windows has been shut down to prevent damage to your computer.Dumping physical memory." at the central nurse's station (cns).

• Brand Name: CNS-6201A
• Type of Device: CENTRAL MONITOR SYSTEM
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia; attn: shama mooman; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; 1-1 tajino; attn: shama mooman; 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: 11816896
• MDR Text Key: 250356773
• Report Number: 8030229-2021-00282
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• 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
• Date Manufacturer Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2015
• 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