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.Attempt #1: (b)(6) 2022 called customer via the provided telephone number for all items under the no information section.An "unknown" answer was received.

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.

• 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: 13737830
• MDR Text Key: 287100144
• Report Number: 2080783-2022-02615
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921131640
• UDI-Public: 04931921131640
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/11/2022

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: 03/11/2022
• Distributor Facility Aware Date: 02/11/2022
• Device Age: 22 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/11/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/11/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 93 YR
• Patient Sex: Male
• Patient Weight: 63 KG