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

Model Number CNS-6201A

Device Problems Image Display Error/Artifact (1304); Output Problem (3005); Power Problem (3010)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/06/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported that their central nurse's station (cns) displayed a "network service disconnect" error message, after which they were unable to open the application.The customer reported that this issue happened multiple times in the past, and that they were always able to resolve it by booting up the cns.No harm or injury reported.The unit was monitoring bedside monitor's (bsm's) at the time of the event.They will be sending their cns in for a repair.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.Additional model information: multiple bsm's were used in conjunction with the cns, and are not the devices that experienced failure.Attempts to obtain the following information were made, but not provided: bsm's: model: ni, s/n: ni.Approximate age of the device: ni.No serial number was provided, so the age of the device is unknown.Device manufacturer date: ni, unique identifier (udi) #: ni.

Event Description

The customer reported that their central nurse's station (cns) displayed a "network service disconnect" error message, after which they were unable to open the application.

Event Description

The customer reported that their central nurse's station (cns) displayed a "network service disconnect" error message, after which they were unable to open the application.

Manufacturer Narrative

Details of complaint: the customer reported that the central nurse's station (cns) displayed a "network service disconnect" error message, after which they were unable to open the application.The customer reported that this issue happened multiple times in the past, and that they were always able to resolve it by booting up the cns.No harm or injury was reported.The unit was monitoring bedside monitor's (bsm's) at the time of the event.They sent the cns in for a evaluation/repair.Service requested / performed: evaluation / repair: on (b)(6) 2020, the unit was cleaned and decontaminated by nihon kohden america repair center (nka rc).No physical damage was noticed.Upon rc evaluation, the reported problem was duplicated.Nka rc replaced both hard drives, part # 9000006111a, with sw version 02-54, which resolved the issue.The unit was tested per the operator's/service manual and the results were recorded on the maintenance check sheet.The unit completed 24 hours of extended testing and operated to the manufacturer's specifications.The repaired unit was shipped to the customer on (b)(6) 2020.No issues have been reported since.Investigation summary: the root cause of the issue is considered to be hard drive failure.In this incident, the device has been in use for 2.5 years with no history of hdd replacement, and hard drive degradation is a high possibility.The reported issue does not require further investigation through capa process.Hha has been completed for the cns-6201a hard drives failure.Capa 19-022 was initiated and rejected based on rationale provided in hha 20-001.The problem does not warrant/require a capa.The following fields are not applicable (na) to the mdr report: b2 b6 b7 d4 lot # & expiration date d6a & d6b d7b f1 - f14 g4 device bla number g5 g7 h7 h9 the following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 additional device information: d10 concomitant medical device: the following devices were used in conjunction with the cns: multiple bsms: model #: ni serial #: ni device manufacturer data: ni unique identifier (udi) #: ni returned to nihon kohden: ni.

• 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 ; 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: 9979687
• MDR Text Key: 200664040
• Report Number: 8030229-2020-00231
• 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: 04/20/2020,01/24/2022

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
• Date Returned to Manufacturer: 04/18/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/20/2020
• Distributor Facility Aware Date: 04/06/2020
• Device Age: 38 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/20/2020
• Initial Date Manufacturer Received: 04/06/2020
• Initial Date FDA Received: 04/20/2020
• Supplement Dates Manufacturer Received: 12/22/2021
• Supplement Dates FDA Received: 01/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2017
• 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: MULTIPLE BEDSIDE MONITOR'S (BSM'S); MULTIPLE BEDSIDE MONITOR'S (BSM'S)