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

Model Number CNS-6201A

Device Problems Computer Software Problem (1112); Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Stops Intermittently (1599); Device Displays Incorrect Message (2591); Program or Algorithm Execution Problem (4033); Program or Algorithm Execution Failure (4036)

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

Event Date 03/23/2018

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the central nurse's station (cns) kept cycling in and out of the cns software and gave a windows "network disconnect" error message.The bme confirmed that the network connection was good.Nihon kohden technical support walked the bme through the process of changing out the cns with a spare unit.The customer's device is a consignment unit and is being sent back to nihon kohden for evaluation.There was no harm reported.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 the central nurse's station (cns) kept cycling in and out of the cns software and gave a windows "network disconnect" error message.

Event Description

The biomedical engineer reported that the central nurse's station (cns) kept cycling in and out of the cns software and gaves a windows "network disconnect" error message.

Manufacturer Narrative

H10: additional narrative: customer biomed stated cns was cycling in and out of the software and give a windows error "network disconnect".Service requested: loaner.Service performed: loaner.Investigation result: nka repair center evaluated the returned device.The reported issue could not be duplicated.No issues were noted.Service history for this device shows the following incidents were reported: (b)(4) - net work disconnect error.The reported issue could not be duplicated at nka repair center.The root cause could not be determined.(b)(4) - customer needed assistance in changing device settings.(b)(4) - current record; reported on (b)(6) 2018.(b)(4) - printer needed a restart to print from device.Customer's service history shows no other network disconnect incidents.The issue was isolated to this device.Since both "network disconnect" incidents could not be duplicated at nka repair center, the cause of error is suspected to be associated with the physical location.However, no other incidents have been reported in the last 12 months.The root cause of the issue could not be determined.Corrected information: g4.Date received by manufacturer: should be 03/23/2018 not 04/20/2018 as listed on mdr initial report.

• 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: 7448225
• MDR Text Key: 106271458
• Report Number: 8030229-2018-00123
• 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: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• 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: 03/11/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/26/2019
• Distributor Facility Aware Date: 06/13/2019
• Device Age: 30 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/26/2019
• Date Manufacturer Received: 06/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1