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

Model Number CNS-6201A

Device Problems No Display/Image (1183); Electrical /Electronic Property Problem (1198)

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

Event Date 05/11/2022

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that they had a generator test and the central nurse's station (cns) went down and would not boot up.No patient harm was reported.Nihon kohden technical support representative (nk tsr) had the bme swap the drives on the cns and then it booted up into the application.Nk tsr advised the bme that the cns should have the hard drives (hdd) replaced.The bme is sending the cns in for service.

Manufacturer Narrative

The biomedical engineer (bme) reported that they had a generator test and the central nurse's station (cns) went down and would not boot up.No patient harm was reported.Nihon kohden technical support representative (nk tsr) had the bme swap the drives on the cns and then it booted up into the application.Nk tsr advised the bme that the cns should have the hard drives (hdd) replaced.The bme is sending the cns in for service.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) 2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 (b)(6) 2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 (b)(6) 2022 emailed customer via microsoft outlook for all items under the no information section.Reply was received and customer stated that they were unable to provide the requested information.

Event Description

The biomedical engineer (bme) reported that they had a generator test and the central nurse's station (cns) went down and would not boot up.No patient harm was reported.Nihon kohden technical support representative (nk tsr) had the bme swap the drives on the cns and then it booted up into the application.Nk tsr advised the bme that the cns should have the hard drives (hdd) replaced.The bme is sending the cns in for service.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that they had a generator test and the central nurse's station (cns) went down and would not boot up.No patient harm was reported.Nihon kohden technical support representative (nk tsr) had the bme swap the drives on the cns and then it booted up into the application.Nk tsr advised the bme that the cns should have the hard drives (hdd) replaced.The bme is sending the cns in for service.Service summary: customers device was inspected by nihon kohden repair center and found the unit was taking longer to get it to boot up to the application and only displayed one monitor.The fan was noisey when the unit was running.Nkrc advised the hard drives are degrading and needs to be replaced.Customer declined service on the unit which was returned to the customer as is.Investigation summary: the customer reported that this cns no longer boots up after an abrupt power loss.The power loss occurred during the generator test.The reported problem was duplicated at nihon kohden.Two hard drives were replaced to fix the device.Hard drives are recommended to be replaced every two years or 20,000 hours of use.The boot up failure occurred at two and half years after it was first put into use.Though possible, it is unlikely that natural hard drive failure coincided with the power loss.It leaves the probable cause of power loss inducing the hard drive failure.Service history for this serial number shows this is an isolated incident.Boot up issue overview- boot up failure, including boot looping, booting into bios, failure to load cns application, and failure to complete the boot up cycle are resulting from hard drive failure.Hard drive failures are caused by environmental factors, maintenance factors, or the hard drive has reached the end of its lifespan (two years).The environmental factors are characterized by an abrupt power loss to the hard drives, such as a power outage, specifically while the drives are being read.These abrupt power losses could damage sensitive internal hard drive components.Additional information: b4 date of this report, e1 initial reporter, g3 date received by manufacturer, g6 type of report, h2 if follow-up, what type?, h6 event problem and evaluation codes, h10 additional manufacturer narrative.

• 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: 14633478
• MDR Text Key: 301351829
• Report Number: 8030229-2022-02889
• 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: 04/13/2023

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/11/2022
• Initial Date FDA Received: 06/08/2022
• Supplement Dates Manufacturer Received: 04/06/2023
• Supplement Dates FDA Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2017
• 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