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

Model Number CNS-6201A

Device Problems Alarm Not Visible (1022); Use of Incorrect Control/Treatment Settings (1126); Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/26/2017

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the central nurse's station (cns) did not alarm for an arrhythmia event, but appeared in the arrhythmia recall.However, a ventilator alarm did sound, which alerted the staff of the event.While troubleshooting the issue, it was discovered that "arrhythmia" was not selected in the recall waveform setting.Fixing this setting resolved the issue.No patient harm was reported.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

The biomedical engineer reported that the central nurse's station (cns) did not alarm for an arrhythmia event, but appeared in the arrhythmia recall.However, a ventilator alarm did sound, which alerted the staff of the event.

Manufacturer Narrative

H10: additional narrative: on (b)(6) 2017, (b)(6) (b) reported the cns-6201a (pu-621ra sn:(b)(6) ) did not alarm when a patient coded "tacky".A ventilator alarmed in the room which helped them get to the patient.Service requested troubleshooting/assistance service performed nk support reviewed the arrhythmia recall and found that at the time of the patient coding, the system did alarm.The system, however, did not record.Upon speaking with nk clinical support, customer clarified that the one tile on the cns was not storing alarms.The patient had been alarming tachycardia and upon reviewing arrhythmia recall, there was no data.No arrhythmias were found to be selected for "create recall waveform".Customer was advised that "create recall waveform" is where they choose what is being stored for the arrhythmia alarms.Nk clinical support provided further explanations on device functionality.Customer also wanted clarification on the grey bell alarm icon.Further information provided.Investigation result the device was placed into service on 01/30/16, which is almost 2 years prior to the reported issue.The warranty was current at the time of reported issue.A review of device history found no previously reported issues with the unit's alarm function.Review with the customer determined the device had alarmed appropriately during the suspected event.Customer was unable to recall the arrhythmia due to incorrect settings.The root cause is determined to be user error/education needed.Customer was advised on device functionality and how to have desired settings to resolve the issue.Based on the given information, this issue is not suspected to be caused by deficient device or design.There were no further reported issues with the unit.Corrected information: g4.Date received by manufacturer: should be 12/26/2017 not 01/23/2018 as listed on mdr initial report.

Event Description

The biomedical engineer reported that the central nurse's station (cns) did not alarm for an arrhythmia event, but appeared in the arrhythmia recall.However, a ventilator alarm did sound, which alerted the staff of the event.

• Brand Name: CNS-6201A
• Type of Device: CENTRAL MONITOR SYSTEM
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia, shinjuku-ku; attn: shama mooman; tokyo, 161-8 560; JA 161-8560
• MDR Report Key: 7213140
• MDR Text Key: 98066735
• Report Number: 8030229-2018-00028
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921114131
• UDI-Public: 4931921114131
• Combination Product (y/n): N
• PMA/PMN Number: K102376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CNS-6201A
• Device Catalogue Number: PU-621RA
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/15/2019
• Distributor Facility Aware Date: 07/15/2019
• Device Age: 26 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/15/2019
• Initial Date Manufacturer Received: 01/23/2018
• Initial Date FDA Received: 01/23/2018
• Supplement Dates Manufacturer Received: 07/15/2019
• Supplement Dates FDA Received: 07/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1