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

Model Number CNS-6201A

Device Problems Loss of Power (1475); Device Inoperable (1663)

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

Event Date 12/18/2017

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the central nurse's station (cns) lost power and shut down unexpectedly.When the device turned back on it got stuck on the blue boot screen.Nihon kohden technical support (nkts) had the bme try forcing the device to start one hard drive at a time.The device did not start into patient monitoring, it was still stuck on the blue boot screen.The customer used a spare cns in place of the malfunctioning one and nkts assisted with configuring the device.The customer sent in the malfunctioning cns for evaluation.Upon completion of the evaluation, it was determined that the reported problem of "stuck on blue boot screen" could not be duplicated through testing, troubleshooting and 4 days extended operation of the device.Review of the device history indicates no previous "could not duplicate" status.The unit was tested per operator's/service manual and the results were recorded on the maintenance check sheet.The unit operates to manufacturer's specifications.

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) lost power and shut down unexpectedly.

Manufacturer Narrative

H10: additional narrative: on (b)(6) 2017, bme (b)(6) at (b)(6) center reported the cns-6201a (pu-621ra, sn: (b)(6) lost power and shut down unexpectedly.When the device turned back on, it got stuck on blue boot screen.Service requested repair.Service performed nk support assisted customer in setting a spare cns in place of the broken one.The unit was returned and evaluated by nka repair center: the unit was cleaned and evaluated.The reported problem of "stuck on blue boot screen" could not be duplicated through testing, troubleshooting and 4 days extended operation of the device.Review of the device history indicates no previous cnd status.The unit was tested per operator's/service manual and the results were recorded on the maintenance check sheet.The unit operates to manufacturer's specifications.Customer was informed of the cnd status and advised that if the issue happened again, it could point to an hdd concern but as of now, it may be a possible hiccup with the raid from the power outage.Investigation result: the cns was put into service on 04/27/2017, which is less than 1 year prior to the reported issue.The warranty was current at the time of reported issue.Review of device history found no previously reported issues with the unit.Nka evaluation was unable to duplicate the reported issue of blue screen.The cns was tested to operate within specifications.There was an unexpected shut down of the cns caused by power loss at the facility.It is unknown if the cns was connected to a ups at the time.Due to the power condition at the facility, this issue is not suspected to be caused by deficient design.The unit was returned to the customer on (b)(6) 2018 as a cnd and there were no further reported issues.Correction: f9.Approximate age of device: incorrectly calculated.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? correction.Additional information.H6.Event problem and evaluation codes.H10.Additional manufacturer narrative.

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) lost power and shut down unexpectedly.

• 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: 7198140
• MDR Text Key: 97791929
• Report Number: 8030229-2018-00016
• 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: 07/25/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2017
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/25/2019
• Distributor Facility Aware Date: 07/25/2019
• Device Age: 22 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/25/2019
• Initial Date Manufacturer Received: 01/16/2018
• Initial Date FDA Received: 01/16/2018
• Supplement Dates Manufacturer Received: 07/25/2019
• 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