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); Device Issue (2379); Human Factors Issue (2948)

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

Event Date 03/20/2018

Event Type  malfunction  

Manufacturer Narrative

The nurse reported that there was a discrepancy between the readings from the bedside monitor (bsm) and the central nurse's station (cns).The bsm waveform looked different than the waveform on the cns when the sensitivity was set the same on both.They also reported that they are experiencing alarm fatigue because their desired default settings were reverting to the previous settings.Nihon kohden clinical application specialist (cas) was on site providing clinical optimization.She found that the customer did not set the defaults correctly and that she has made the correct changes to the bsm, which resolved the issue.No patient harm was reported.

Event Description

The nurse reported that there was a discrepancy between the readings from the bedside monitor (bsm) and the central nurse's station (cns).The bsm waveform looked different than the waveform on the cns when the sensitivity was set the same on both.They also reported that they are experiencing alarm fatigue because their desired default settings were reverting to the previous settings.

Event Description

The nurse reported that there was a discrepancy between the readings from the bedside monitor (bsm) and the central nurse's station (cns).The bsm waveform looked different than the waveform on the cns when the sensitivity was set the same on both.They also reported that they are experiencing alarm fatigue because their desired default settings were reverting to the previous settings.

Manufacturer Narrative

H10: additional narrative: on (b)(6) 2018, (b)(6) at (b)(6) hospital reported issues with alarm fatigue and waveform reading discrepancies on the cns-6201a (pu-621ra sn: (b)(6) and bsms.Service requested: troubleshooting/assistance.Service performed: onsite clinical support found the default settings to not be set correctly.The correct changes were made to the bsm.Investigation result: the device warranty began 03/30/2017, which is 1 year prior to reported issue.The root cause is determined to be user error/education needed.There were incorrect settings on the device which led to discrepancies in the waveform and alarm limits.Issue was resolved with assistance of clinical support in correcting default settings.The device was in use with a patient and there was no reported patient harm.Based on the given information, this complaint record will be closed corrected information: g4.Date received by manufacturer: should be 03/20/2018 not 04/18/2018 as listed on mdr initial report.Additional information: b4.Date of this report.D11& c2 concomitant medical products.F6.Date user facility/importer became aware of the event.F7.Type of report.F11.Date report sent to fda.F13.Date report sent to manufacturer.G4.Date received by manufacturer.G7.Type of report.H2.If follow-up, what type? additional information.Correction.H6.Event problem and evaluation codes.H10.Additional manufacturer narrative.D11& c2 concomitant medical products: bedside monitor (model/serial unknown).

• 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: 7442002
• MDR Text Key: 105904684
• Report Number: 8030229-2018-00115
• 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: 08/15/2019

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: 08/15/2019
• Distributor Facility Aware Date: 05/28/2019
• Device Age: 25 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/15/2019
• Initial Date Manufacturer Received: 04/18/2018
• Initial Date FDA Received: 04/18/2018
• Supplement Dates Manufacturer Received: 05/28/2019
• Supplement Dates FDA Received: 08/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1
• Treatment: BEDSIDE MONITOR (BSM)