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); Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Issue (2379); Human Factors Issue (2948)

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

Event Date 01/29/2018

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the central nurse's station (cns) rebooted when trying to admit a patient.After some troubleshooting, the issue was resolved by changing the channel on the receiver card.No patient harm was reported.

Event Description

The customer reported that the central nurse's station (cns) rebooted when trying to admit a patient.

Event Description

The customer reported that the central nurse's station (cns) rebooted when trying to admit a patient.

Manufacturer Narrative

Details of the complaint on (b)(6) 2018, customer at (b)(6) reported the cns (pu-621ra sn: (b)(6)) would reboot whenever they attempted to admit or discharge a patient in slot 13 of the cns application.On 01/30/18, the customer reported changing the channel on the org receiver card fixed the issue and he was able to admit/discharge without the cns application rebooting.Investigation result.Per nkc dhr, the unit has had no history of ncmr, deviation, or capa during manufacturing of the device.The device has not been refurbished and there were no discrepancies or unusual findings before device release that might relate to the reported issue.The cns warranty began 06/30/17.Review of device c4c history found no previously reported issues with the unit.Review of tickets opened at (b)(6) found no additional case of a rebooting cns reported.Information regarding the org involved was not provided.The unit was not returned to nka and no evaluation was performed.Review of tickets opened at other customer facilities found 2 tickets relating to cns restart with admit/discharge of a patient: ticket (b)(4) (notification (b)(4)) reported 12/20/17 at (b)(6).The issue was found to be caused by hdd failure.This is not suspected to be related to the current issue.Ticket (b)(6) (notification (b)(6)) reported 07/14/18 at (b)(6) med.Center.The issue was isolated to an org however evaluation of the unit at nka was unable to duplicate the issue.No additional information was collected at the time of the incident to further the investigation.From the information available, the root cause could not be determined.The facility has not reported further issues with the cns after 01/29/18.No adverse trend is found as this appears to be an isolated incident at the facility.Investigation conclusion.No additional information was collected at the time of the incident to further the investigation.From the information available, the root cause could not be determined.The facility has not reported further issues with the cns after 01/29/18.No adverse trend is found as this appears to be an isolated incident at the facility.Additional information: b4.Date of this report; e2-3.Initial reporter - occupation; 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; h6.Event problem and evaluation codes; h10.Additional manufacturer narrative.

• 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: 7301043
• MDR Text Key: 101469679
• Report Number: 8030229-2018-00054
• 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: 01/22/2020

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: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/22/2020
• Distributor Facility Aware Date: 01/21/2020
• Device Age: 12 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/22/2020
• Initial Date Manufacturer Received: 02/27/2018
• Initial Date FDA Received: 02/27/2018
• Supplement Dates Manufacturer Received: 01/21/2020
• Supplement Dates FDA Received: 01/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1