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

Model Number CNS-6201A

Device Problems Use of Incorrect Control/Treatment Settings (1126); Incorrect Interpretation of Signal (1543); Device Issue (2379); Human Factors Issue (2948)

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

Event Date 05/31/2018

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the central nurse's station (cns) gave an incorrect tachy alarm when the patient did not have a fast heart beat.Changing trace 1 to lead i resolved the issue.The patient's heart rate dropped from the 200s to 115, which was correct according to the staff.No patient harm was reported.

Event Description

The biomedical engineer reported that the central nurse's station (cns) gave an incorrect tachy alarm when the patient did not have a fast heart beat.

Manufacturer Narrative

(b)(6) reported on (b)(6) 2018 that their pu-621ra (sn: (b)(6)) was alarming for tachycardia, but the patient's hr was not that fast based on nurse checking.Service requested: troubleshooting.The customer sent a text with a photo of the patient's waves and the t-waves were peaked.Clinical application specialist kim bates recommended that the customer monitor another lead for trace 1 instead of lead ii.The customer changed trace 1 to lead i and this resolved the issue.The patient's hr displayed dropped from 200 to 115, which was correct according to the hospital staff.Clinical application specialist then explained to the customer that if the t-wave is peaked, this can be recognized as another qrs complex, resulting in double-counting.Investigation result(s): peaked t-waves can be caused by the patient if they are: hyperkalemic; have pericarditis; taking certain medications (such as digoxin, quinide, overdosing on medication); cardiac issues; ecg lead misplacement; and etcetera.In this case, the customer had chosen the incorrect lead settings for monitoring their patient.The issue was resolved through the customer choosing a different lead for trace 1 that allowed proper monitoring of the patient.The device serial number history shows that there have been no further/previously reported issues nor servicing for this device double counting.The root cause of the issue has been identified to be user error/user education as the incorrect lead settings had been chosen to monitor the patient.Clinical application specialist educated the customer on how to get a more accurate reading and how double counting can result from peaked t-waves.Trending analysis found two similarly reported issues regarding pu-621ra and double counting hr.All three of the reported issues were at different facilities and resolved through adjusting lead configuration.There is no suspected adverse trend nor indication of design deficiency.Investigation by qe has been completed as the root cause of the issue has been identified and investigational information within the record documents that the issue was resolved through customer choosing a proper lead configuration to monitor their patient.Corrected information: g4.Date received by manufacturer: should be 05/31/2018 not 06/29/2018 as listed on mdr initial report.

Event Description

The biomedical engineer reported that the central nurse's station (cns) gave an incorrect tachy alarm when the patient did not have a fast heart beat.

• 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: 7651667
• MDR Text Key: 112852898
• Report Number: 8030229-2018-00240
• 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: 07/24/2019

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: 07/24/2019
• Distributor Facility Aware Date: 07/11/2019
• Device Age: 27 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/24/2019
• Initial Date Manufacturer Received: 06/29/2018
• Initial Date FDA Received: 06/29/2018
• Supplement Dates Manufacturer Received: 07/11/2019
• Supplement Dates FDA Received: 07/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1