MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CNS-6801A; CENTRAL MONITOR SYSTEM

Model Number CNS-6801A

Device Problems Unintended Power Up (1162); Defective Component (2292); Application Program Problem (2880); Inappropriate or Unexpected Reset (2959); Power Problem (3010); Unintended Application Program Shut Down (4032)

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

Event Date 09/23/2021

Event Type  malfunction  

Manufacturer Narrative

The customer reported that this central nurse's station (cns) is in constant boot cycle.Per the customer, the unit would constantly reboot, before they would cycle the unit and the issue would be corrected, but now the issue is continuous.The customer will send in the unit to be repaired.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 this central nurse's station (cns) is in constant boot cycle.There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that this central nurse's station (cns) is in constant boot cycle.Per the customer, the unit would constantly reboot, before they would cycle the unit and the issue would be corrected, but now the issue is continuous.The customer will send in the unit to be repaired.There was no patient injury reported.Investigation summary: the device was returned to nka for evaluation and repair.The model, serial number, and all labels were verified.The customer reported issue could not be verified by the repair technician.However, the repair technician did observe that the unit was displaying a "system maintenance is required" message and noted that the hard drives are faulty.To repair the unit, the following component(s) are recommended to be replaced: 9000063437 hdd, internal, cns-6801a 2 ea.This device was put into service on 12/30/2018.The service history for this serial number shows no similar reports and/or tickets.Root cause: the cns is operating on the original hard disk drives (hdd).Per nka repair center both hard drives on the unit were deemed faulty.The operating time for an hdd is (b)(4) hours or two years (ref.(b)(4) & cns-6801a) and there is no history of the hdd being replaced.This is likely to be the contributing factor for the issue.No corrective actions would be warranted at this time.Attempt # 1: 10/15/2021 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i do not have any information.B6 attempt # 1: 10/15/2021 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i do not have any information.B7 attempt # 1: 10/15/2021 emailed the customer via microsoft outlook for patient information: the customer replied by stating; i do not have any information.D10 attempt # 1: 10/15/2021 emailed the customer via microsoft outlook for device information: the customer replied by stating; i do not have any information.Manufacturer references # (b)(4).

Event Description

The customer reported that this central nurse's station (cns) is in constant boot cycle.There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that this central nurse's station (cns) was in a constant boot loop.The customer sent the unit in to be repaired.No patient harm was reported.Investigation summary: the cns was evaluated at nihon kohden america.The reported boot loop issue was not duplicated.However, the cns was displaying a "system maintenance required" message.This is an indication of hard drive failure.Both hard drives were replaced to resolve the issue.This cns was installed on (b)(6) 2018.The service history for this serial number shows a previous incident reported under ticket (b)(4) on (b)(6) 2019.The incident was caused by a ups failure.No hard drive failures were noted.Between (b)(6) 2021 and the date of installation, the cns had been in service for more than 2 years.It is presumed that the age of the hard drive (older than preventative maintenance replacement of 2 years, or 20,000 hours) combined with previous abrupt power loss were the factors in hard drive failure.Boot up failures, including boot looping, booting into the bios, failure to load the cns application, and failure to complete the boot up cycle are results of hard drive failure.Hard drive failures are caused by environmental factors, maintenance factors, or the hard drive having 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.Environmental factors include: · power outages · generator tests · uninterruptable power supply (failure) · power outlet failure maintenance related factors: the cns device is designed such that the internal components are protected from excessive heat.When excessive heat builds up, either from hot ambient air, or clogged heat fans on the cns tower, the device will shut down as a protective measure.These shutdowns may impact hard drive lifespan.The cns device requires regular maintenance, as outlined in the operator's manual.When stored for an extended period of time, operation checks should be performed.In short, the symptoms of the device not being able to boot up is related to its internal hard drives.This is indicative of the device needing maintenance and/or service.Additional information: b4 date of this report g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h3 device evaluated by manufacturer? h6 event problem and evaluation codes h10 additional manufacturer narrative.

Event Description

The customer reported that this central nurse's station (cns) was in a constant boot loop.There was no patient injury reported.

• Brand Name: CNS-6801A
• 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: 12682736
• MDR Text Key: 280207353
• Report Number: 8030229-2021-01846
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921131640
• UDI-Public: 04931921131640
• 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,Followup
• Report Date: 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CNS-6801A
• Device Catalogue Number: PU-681RA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2017
• 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
• Treatment: NI.; NI.; NI.