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

Model Number CNS-6801A

Device Problem Device Alarm System (1012)

Patient Problems Arrhythmia (1721); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/05/2023

Event Type  Death  

Manufacturer Narrative

Details of the complaint: the nurse reported that they had a patient expire while being monitored on a telemetry transmitter (tele).They are requesting us to check to see if it is possible to see if at any point if the alarms were silenced without making the proper calls.They have reviewed full disclosure / arrhythmia recall and can see where the alarms occurred.They are not alleging that nk equipment directly contributing to patient death or harm, but are conducting an internal investigation to see if the proper procedures were not followed.The patient was being monitored by 6west-tx08 on central nurse's station cns -1189 the event occurred on (b)(6) 2023 around midnight.Investigation conclusion: the customer requested a review of the device logs for their internal investigation and below are the log findings: at 23:52 on (b)(6) 2023, an operation was performed to cancel the alarm.Log: on (b)(6) 2023 23:52:23 alarms silenced bed, 6wtx08, patient.This seems to be the release of the bradycardia alarm that occurred at 23:47.Log: bed, 6wtx08, patient, priority, warning, msg, bradycardia, starttime, 23:47:54, endtime, 23:55:12.After that, there is no history of alarm cancellation.It appears that asystole was detected at 23:57 on (b)(6), and then discharged at 1:16 on (b)(6).On (b)(6) 2023 23:57:26 bed, 6wtx08, patient, priority, crisis, msg, asystole, starttime, 23:56:13, endtime, 23:57:14.On (b)(6) 2023 1:16:12 discharged bed, 6wtx08, patient.Review of the device logs confirmed that the cns properly alarmed.There was no indication of cns malfunction.Review of the complaint device's serial number does not show any other reports for this issue.Review of the customer's complaint history also does not show any trends for the issue.Attempt #1 on (b)(6) 2023 tech support sent emailed the customer the adverse event form for all items under the no information section.The nurse replied that they would not be providing this information.Telemetry transmitter: model: ni.Sn: ni.

Event Description

The nurse reported that they had a patient expire while being monitored on a telemetry transmitter (tele).They are requesting us to check to see if it is possible to see if at any point if the alarms were silenced without making the proper calls.They have reviewed full disclosure / arrhythmia recall and can see where the alarms occurred.They are not alleging that nk equipment directly contributing to patient death or harm, but are conducting an internal investigation to see if the proper procedures were not followed.The patient was being monitored by 6west-tx08 on central nurse's station cns -1189 the event occurred on (b)(6) 2023 around midnight.The customer requested a review of the device logs for their internal investigation and below are the log findings: at 23:52 on (b)(6) 2023, an operation was performed to cancel the alarm.Log: on (b)(6) 2023 23:52:23 alarms silenced bed, 6wtx08, patient.This seems to be the release of the bradycardia alarm that occurred at 23:47.Log: bed, 6wtx08, patient, priority, warning, msg, bradycardia, starttime, 23:47:54, endtime, 23:55:12.After that, there is no history of alarm cancellation.It appears that asystole was detected at 23:57 on (b)(6), and then discharged at 1:16 on (b)(6).On (b)(6) 2023 23:57:26 bed, 6wtx08, patient, priority, crisis, msg, asystole, starttime, 23:56:13, endtime, 23:57:14, on (b)(6) 2023 1:16:12 discharged bed, 6wtx08, patient.

• 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; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 17892229
• MDR Text Key: 325227722
• Report Number: 8030229-2023-03793
• 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: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/06/2023

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?: No
• 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: 09/07/2023
• Initial Date FDA Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2019
• 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
• Treatment: TELEMETRY TRANSMITTER.
• Patient Outcome(s): Death