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-Device Interface Problem (2949)

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

Event Date 03/23/2018

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that they were able to set the alarm volume to off on the central nurse's station (cns).That setting should not be available, and the nurses were turning the volume off and the alarms could not be exhibited.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 they were able to set the alarm volume to off on the central nurse's station (cns).

Event Description

The biomedical engineer reported that they were able to set the alarm volume to off on the central nurse's station (cns).

Manufacturer Narrative

H10: additional narrative: customer stated that the alarm volume setting for their unit was set to off.The customer stated that they are able to set the volume to off and that the setting should not be available.The customer stated that they want to set the minimum alarm limit as the nurses were turning alarms off.Service requested: troubleshooting service performed: troubleshooting technical support walked the customer through editing the alarm volume limit in system setup > system configurations > alarms.Investigation results: within the "adjusting the alarm sound volume" section of the device operator's manual, it is stated that the user is unable to set the alarm sound volume to off.However, the alarms limits (lower) are able to be turned off and as a result the device can be "silenced." per trending analysis (view below), similar cases to that reported were unable to found/were not reported by other customers.This indicates that this issue is an extremely rare occurrence and is indicative of user error.The root cause of the issue was identified to be user error in configuring their alarm settings.The customer's issue was resolved through technical support educating the customer on how to set the minimum alarm limit through the device's alarm settings so that alarms would continue to sound.Corrected information: g4.Date received by manufacturer: should be 03/23/2018 not 04/20/2018 as listed on mdr initial report additional information: b4.Date of this report 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 the following fields are not applicable (n/a) to this report: a2 - a6 b2 b6 b7 d4 lot # & expiration date d6 - d7 d9 d11& c2 f10 g6 g8 h7 h9.

• 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: 7448214
• MDR Text Key: 106203362
• Report Number: 8030229-2018-00121
• 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: 08/08/2019

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: 08/08/2019
• Distributor Facility Aware Date: 05/08/2019
• Device Age: 33 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/08/2019
• Initial Date Manufacturer Received: 04/20/2018
• Initial Date FDA Received: 04/20/2018
• Supplement Dates Manufacturer Received: 05/08/2019
• Supplement Dates FDA Received: 08/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1