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

Model Number CNS-6801A

Device Problems No Audible Alarm (1019); Audible Prompt/Feedback Problem (4020)

Patient Problem Apnea (1720)

Event Date 12/14/2021

Event Type  Death  

Manufacturer Narrative

The customer reported that the central nurse's station (cns) did not alarm for apnea.According to the customer, the patient was being monitored normally, but when the patient went into respiratory arrest, the cns did not alarm.The patient expired a day after the device failed to alarm.Biomed tested the system afterwards and everything worked fine.Technical support (ts) had the customer print out the investigation documents.Attempt # 1: 12/28/2021 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 12/29/2021 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3: 01/05/2022 emailed the customer via microsoft outlook for patient information: no reply was received.Additional model information: concomitant medical device: the following device was used in conjunction with the cns: co2 monitor: model #: ni, serial #: ni, device manufacturer data: ni, unique identifier (udi) #: ni, returned to nihon kohden: ni.

Event Description

The customer reported that the central nurse's station (cns) did not alarm for apnea.The patient expired a day after the device failed to alarm.

• 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: 13192047
• MDR Text Key: 283411168
• Report Number: 2080783-2022-02306
• 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: 01/07/2022

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: 01/07/2022
• Distributor Facility Aware Date: 12/14/2021
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/07/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CO2 MONITOR
• Patient Outcome(s): Death