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

Model Number CNS-6201A

Device Problems Defective Component (2292); Power Problem (3010); Unintended Application Program Shut Down (4032)

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

Event Date 09/03/2021

Event Type  malfunction  

Event Description

The customer reported that the central nurse's station (cns) keeps crashing exiting out of the application and gets hdd port 1 errors.There was no patient injury reported.

Manufacturer Narrative

The customer reported that the central nurse's station (cns) keeps crashing exiting out of the application and gets hdd port 1 errors.The customer also reported that they're not able to see patient data in their full disclosure and it is only affecting some beds.The customer wants to send in the unit for evaluation/repair.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.

Manufacturer Narrative

Details of complaint: the customer reported that the central nurse's station (cns) keeps crashing exiting out of the application and gets hdd port 1 errors.The customer also reported that they're not able to see patient data in their full disclosure and it is only affecting some beds.The customer wants to send in the unit for evaluation/repair.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.Investigation summary: the root cause of the hdd port error as well as the full disclosure issue is considered to be hard drive failure.In this incident, the device has been in use for four and a half years with no history of hdd replacement, and hard drive degradation is a high possibility.Hard drives are routine service component, it is expected to be replaced periodically or as indicated.Its failure has low impact to patient safety.The possible cause for the full disclosure issue could be attributed to the hard drive failure as well.The hard drive failure led to the cns crashing and one of the causes for the full disclosure to not be displayed is if the cns where the bed is being monitored is turned off.The reported issue does not warrant/require further investigation through capa process.The following fields are not applicable (na) to this report: b2 d4 lot # & expiration date d6a & d6b d7b f1 - f14 g4 device bla number g5 g7 h2 h7 h9 the following fields contain no information (ni), as attempts to obtain information were made, but not provided: a2 - a6 attempt # 1: (b)(6) 2021 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6) 2021 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 (b)(6)2021 emailed the customer via microsoft outlook for patient information: the customer replied with n/a for all patient information.No other information was provided.B6 attempt # 1: (b)(6) 2021 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6) 2021 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 (b)(6) 2021 emailed the customer via microsoft outlook for patient information: the customer replied with n/a for all patient information.No other information was provided.B7 attempt # 1: (b)(6) 2021 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: (b)(6) 2021 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3 (b)(6) 2021 emailed the customer via microsoft outlook for patient information: the customer replied with n/a for all patient information.No other information was provided.Manufacturer references # 300267407-118897 follow up 001.

Event Description

The customer reported that the central nurse's station (cns) keeps crashing exiting out of the application and gets hdd port 1 errors.There was no patient injury reported.

• 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: 12566160
• MDR Text Key: 281085977
• Report Number: 8030229-2021-01750
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• 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: 04/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2016
• 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