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)

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 the central nurse's station (cns) monitoring software would not stay on and kept crashing while the device was in patient use.The device was returned to nihon kohden and is pending evaluation.No patient harm was reported.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) monitoring software would not stay on and kept crashing while the device was in patient use.

Manufacturer Narrative

The biomedical engineer reported that the central nurse's station (cns) monitoring software would not stay on and kept crashing while the device was in patient use.The device as returned to nihon kohden and has since been cleaned and evaluated.The reported problem of "monitoring software crashing" was duplicated, hard drives were re-imaged to resolve the issue.The unit was tested per operator's/service manual and completed 4 days of extended testing.The unit operates to manufacturer's specifications.Unit has been sent back to the customer.

Manufacturer Narrative

H10: additional narrative: customer reported that their monitoring software was crashing.Service requested: repair/loaner.Service performed: repair/loaner.The unit was cleaned and evaluated.The reported problem of "monitoring software crashing" was duplicated, hard drives were re-imaged to resolve the issue.The unit was tested per operator's/service manual and completed 4 days of extended testing.The unit operates to manufacturer's specifications.Investigation results: the root cause of the issue has been identified to be corruption of software.Over time, age and use increases the likelihood of failing parts and possible mishandling/abuse by customer can contribute to device failing.The device service manual recommends regular maintenance/periodic inspection of the unit to detect degradation and prevent loss of function of the unit.The operator's/service manual also states that the cns needs to be restarted once every (3) months otherwise operation becomes unstable and monitoring may stop.The customer's issue was resolved through reimaging the device's hard drives.Reimaging the hard drive resets the drive(s) back to original specifications (factory settings).The device service record shows that there have not been any other complaints or servicing regarding the reported issue and this device.Trending analysis shows that similar reported complaints for the product could not be found, therefore there is no suspected adverse trend nor indication of design deficiency.An updated dhr form was received by nkc and has been attached to the complaint record.It does not change the outcome of the investigation.Corrected information: g4.Date received by manufacturer: should be 03/23/2018 not 04/20/2018 as listed on mdr initial report.

Event Description

The biomedical engineer reported that the central nurse's station (cns) monitoring software would not stay on and kept crashing while the device was in patient use.

• 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: 7448218
• MDR Text Key: 106396137
• Report Number: 8030229-2018-00122
• 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,Followup
• Report Date: 08/21/2019

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: 04/10/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/21/2019
• Distributor Facility Aware Date: 08/20/2019
• Device Age: 79 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/21/2019
• Date Manufacturer Received: 08/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: NOT APPLICABLE
• Patient Sequence Number: 1
• Treatment: NOT APPLICABLE.