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

Model Number CNS-6801A

Device Problem Protective Measures Problem (3015)

Patient Problem Encephalopathy (1833)

Event Date 01/14/2022

Event Type  Death  

Manufacturer Narrative

The customer reported that their patient spo2 levels dropped and that the central nurse's station (cns) did not alarm during this event.The customer also stated that their staff was only notified of an alarm for a change in rhythm, and when they went to check in on the patient they found that the patient expired.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 that their patient spo2 levels dropped and that the central nurse's station (cns) did not alarm during this event.The customer also stated that their staff was only notified of an alarm for a change in rhythm, and when they went to check in on the patient they found that the patient expired.

Event Description

The customer reported that the central nurse's station (cns) did not alarm when the patient's spo2 levels dropped.It was only noticed by the staff when they checked on the patient, at which time they discovered that the patient had expired.

Manufacturer Narrative

Details of complaint: the customer reported that the central nurse's station (cns) did not alarm when the patient's spo2 levels dropped.It was only noticed by the staff when they checked on the patient, at which time they discovered that the patient had expired.Investigation summary: the customer had reported that the cns did not alarm on (b)(6) 2022 between 9:00am - 10:05am pst, resulting in patient expiration.The cns event logs were sent in for evaluation.The log analysis reveals a number of alarms for the reported time frame as well as logs of alarms being silenced.This would indicate that the cns did have the ability to alarm, and clinicians were unable to be notified of the alarm due to silencing of the alarms.Unintentional silencing of the alarm may have affected the response of clinicians to the patient's event.A serial number review of the reported device does not reveal additional related complaints.A complaint history review of the customer's account does not reveal similar complaints.There is no evidence of an nk device malfunction that may have contributed to the reported issue.The following fields contain no information (ni), as an attempt to obtain the information was made, but not provided.A5 - a6 b6 d10 attempt #1 02/14/2022 called customer via the provided telephone number for all items under the no information section.They replied that the information was unknown.

• 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: 13737887
• MDR Text Key: 287100385
• Report Number: 8030229-2022-02615
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/25/2023

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
• Initial Date Manufacturer Received: 02/11/2022
• Initial Date FDA Received: 03/11/2022
• Supplement Dates Manufacturer Received: 10/23/2023
• Supplement Dates FDA Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2020
• 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
• Patient Outcome(s): Death
• Patient Age: 93 YR
• Patient Sex: Male
• Patient Weight: 63 KG