MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CNS-6201A; CENTRAL MONITOR SYSTEM

Model Number CNS-6201A

Device Problems Device Alarm System (1012); No Audible Alarm (1019); Protective Measures Problem (3015)

Patient Problem Ventilator Dependent (2395)

Event Date 06/30/2021

Event Type  Injury  

Manufacturer Narrative

The biomedical engineer (bme) reported that there was a missed alarm on the central nurse's station (cns) that caused patient injury.The patient is now on life support.They stated that this appeared to be caused by human error, and not the fault of our equipment and that the alarms may have been changed / missed.Time of event - approx.1:25am (b)(6) 2021.They requested that we look at the logs to verify the following: if any alarms were changed from 6:45pm (b)(6) 2021 thru 1:25am (b)(6) 2021.If possible, see if an alarm was missed possibly due to human error.-verify that the event was not caused by our telemetry / cns devices.He is requesting that we investigate the logs to validate that it was a human error and not an issue with the nk device.Additional device information: concomitant medical device: the following device(s) were being used in conjunction with the cns.Telemetry transmitter model: zm-530pa.Sn: (b)(4).

Event Description

The biomedical engineer (bme) reported that there was a missed alarm on the central nurse's station (cns) that caused patient injury.The patient is now on life support.They stated that this appeared to be caused by human error, and not the fault of our equipment and that the alarms may have been changed / missed.Time of event - approx.1:25am (b)(6) 2021.They requested that we look at the logs to verify the following: if any alarms were changed from 6:45pm (b)(6) 2021 thru 1:25am (b)(6) 2021.If possible, see if an alarm was missed possibly due to human error.Verify that the event was not caused by our telemetry / cns devices.He is requesting that we investigate the logs to validate that it was a human error and not an issue with the nk device.

• Brand Name: CNS-6201A
• 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: 12257015
• MDR Text Key: 269601196
• Report Number: 2080783-2021-01500
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921114131
• UDI-Public: 04931921114131
• 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: 07/30/2021

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-6201A
• Device Catalogue Number: PU-621RA
• 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: 07/30/2021
• Distributor Facility Aware Date: 06/30/2021
• Device Age: 48 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/30/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening