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

Model Number CNS-6201A

Device Problems Image Display Error/Artifact (1304); Application Program Problem (2880); Output Problem (3005); Application Program Freezes, Becomes Nonfunctional (4031)

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

Event Date 10/11/2021

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) had frozen and the bme attempted to reboot the station by pressing the power button to shut it off.When the station was rebooted, the application is now stuck in the cns splash screen.No patient harm was reported.Nihon kohden technician advised the bme that it is likely one of the hdd drives that is corrupt in the cns.The bme had a spare hdd drive and was able to rebuild it and install it in the cns which resolved the reported issue.There were no further issues with the cns.

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 biomedical engineer (bme) reported that the central nurse's station (cns) froze.The bme attempted to reboot the cns by pressing the power button to shut it off.When the cns was rebooted, it was stuck on the cns application splash screen.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the central nurse's station (cns) froze.The bme attempted to reboot the cns by pressing the power button to shut it off.When the cns was rebooted, it was stuck on the cns application splash screen.Nihon kohden technical support (nk ts) advised the bme that one of the hard disk drives (hdds) was likely corrupt.The bme installed a spare hdd and once the riad was allowed to rebuild, the issue was resolved.No patient harm or injury was reported.Investigation summary: nihon kohden (nk) was able to confirm the reported issue was due to a malfunctioning/damaged hard disk drive (hdd), due to user related errors, (file corruption and lack of preventative maintenance), which lead to hdd damage and caused error messages and startup issues, as reported.The hdd was replaced by the customer, by using a spare hdd at the facility, to resolve the issue.A review of historical data indicates the device, (pu-621ra, serial number (b)(6)), was delivered to the customer on (b)(6) 2015 and the warranty expired on (b)(6) 2020.The hdd had not been replaced in approximately 5 (five) years, potentially indicating a lack proper preventative maintenance performed by the customer.During the review, it was discovered there was only (1) one failure for this device at this facility, in the past (3) three years.

• 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; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 12780746
• MDR Text Key: 282724370
• Report Number: 8030229-2021-01912
• 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: 03/24/2023

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-6201A
• Device Catalogue Number: PU-621RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2021
• Initial Date FDA Received: 11/09/2021
• Supplement Dates Manufacturer Received: 03/20/2023
• Supplement Dates FDA Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2014
• 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