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

Model Number CNS-6801A

Device Problems Use of Incorrect Control/Treatment Settings (1126); Incorrect Measurement (1383); Use of Device Problem (1670); Data Problem (3196)

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

Event Date 11/08/2021

Event Type  malfunction  

Manufacturer Narrative

The customer also mentioned that there were clinical changes.According to the customer, the settings changed allegedly without user input.Technical support (ts) walked the customer through changing the settings at the cns.Ts asked the customer to collect the logs from the cns to find out what caused the settings changes.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 8 beds in the internal care unit (icu) with incorrect units of measure at the central nurse's station (cns).There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that the units of measurement at the central nurse's station (cns) were unknowingly changed to incorrect measurements, affecting the monitoring of 8 beds in the icu).Technical support (ts) walked the customer through changing the settings back at the cns.No patient harm was reported.Investigation summary: the customer was asked to provide the cns and bsm event logs to investigate the cause of the setting changes; however, the logs were not provided in a timely manner.As event logs can only contain data going back 5 days, logs pulled outside this time span will not contain data relevant to the reported event.As such, a root cause cannot be determined.The issue was resolved after ts manually changed the settings to what the customer needed.A similar issue was reported at a later date in ticket 132624 and the log analysis in this ticket revealed that the setting changes were performed by a user.As such, the root cause is likely related to user input.A serial number review of the reported device does not reveal additional related complaints.

Event Description

The customer reported that the units of measurement at the central nurse's station (cns) were unknowingly changed to incorrect measurements, affecting the monitoring of 8 beds in the icu).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: 12954062
• MDR Text Key: 285679909
• Report Number: 8030229-2021-02060
• 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
• Report Date: 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2018
• 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