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

Model Number CNS-6801A

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)

Patient Problems High Blood Pressure/ Hypertension (1908); Respiratory Failure (2484); Unspecified Kidney or Urinary Problem (4503)

Event Date 09/03/2022

Event Type  Death  

Event Description

The customer reported that they recently had a patient expired so they requested to have the log files looked at.According to the customer, the patient expired while being monitored on the central nurse's station (cns) on (b)(6) 2022.

Manufacturer Narrative

The customer reported that they recently had a patient expired so they requested to have the log files looked at.According to the customer, the patient expired while being monitored on the central nurse's station (cns) on (b)(6) 2022.The concern is that if patient co2 had been trending up and was not reflected in the etco2 monitoring.The customer's desire is to test the unit to ensure accuracy to rule out mechanical issue.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: date of birth.Attempt # 1: 09/09/2022 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 09/14/2022 emailed the customer via microsoft outlook for patient information: the customer replied with the requested information except the patient's date of birth.Attempt # 1: 09/09/2022 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 09/14/2022 emailed the customer via microsoft outlook for patient information: the customer replied with the requested information except the patient's date of birth.Attempt # 1: 09/09/2022 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 09/14/2022 emailed the customer via microsoft outlook for patient information: the customer replied with the requested information except the patient's date of birth.Additional model information: concomitant medical device: the following device was used in conjunction with the cns: bsm: model #: ni, serial #: ni, device manufacturer data: ni, unique identifier (udi) #: ni, returned to nihon kohden: ni.Additional model information: concomitant medical device: the following device was used in conjunction with the cns: hamilton g5 ventilator: model #: ni, serial #: ni, device manufacturer data: ni, unique identifier (udi) #: ni, returned to nihon kohden: ni.Additional model information: d10 concomitant medical device: the following device was used in conjunction with the cns: g9: model #: ni, serial #: ni, device manufacturer data: ni, unique identifier (udi) #: ni, returned to nihon kohden: ni.Additional model information: d10 concomitant medical device: the following device was used in conjunction with the cns: sidestream: model #: ni, serial #: ni, device manufacturer data: ni, unique identifier (udi) #: ni, returned to nihon kohden: ni.

• 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
• MDR Report Key: 15555947
• MDR Text Key: 301325100
• Report Number: 2080783-2022-03098
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921131640
• UDI-Public: 04931921131640
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/06/2022
• Distributor Facility Aware Date: 09/07/2022
• Device Age: 13 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/06/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BSM.; G9.; HAMILTON G5 VENTILATOR.; SIDESTREAM DEVICE.
• Patient Outcome(s): Death
• Patient Age: 4 MO
• Patient Sex: Male
• Patient Weight: 6 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White