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

Model Number CNS-6201A

Device Problems Electrical Power Problem (2925); Unintended Application Program Shut Down (4032)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/15/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that the facility had a failed generator test and lost power for the entire hospital, including backup power (ups-3rd party device).This caused the central nurse's station (cns) to shut down while monitoring transmitter devices and would not boot back up into windows.No patient harm was reported.The transmitter devices are currently being monitored by an rns in the department.The cns has been returned to nihon kohden and is awaiting evaluation.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 when additional information becomes available.Additional device information: the following devices were being used in conjunction with the cns: transmitters: no model numbers and serial numbers were provided, ups (3rd party device): no model and serial number was provided, rns: no model and serial number was provided.

Event Description

It was reported that the facility had a failed generator test and lost power for the entire hospital, including backup power (ups-3rd party device).This caused the central nurse's station (cns) to shut down while monitoring transmitter devices.No patient harm was reported.

Event Description

It was reported that the facility had a failed generator test and lost power for the entire hospital, including backup power (ups-3rd party device).This caused the central nurse's station (cns) to shut down while monitoring transmitter devices.No patient harm was reported.

Manufacturer Narrative

Details of the complaint: on (b)(6) 2019, customer at (b)(6) hospital reported the cns-6201a (pu-621ra sn: (b)(6) ) would not boot into windows.The device had been stalled at the operation system set up screen since the night of 11/15/19.The facility had a failed generator test on 11/15/19 and the entire hospital lost power, including back up power.Service requested/performed: the unit was returned to nka for repair; the unit was cleaned and decontaminated.The model, serial number, and all labels were verified.Physical evaluation: there was no physical damage in initial evaluation.Verify the complaint: cns did not boot up into windows.Problem reported was duplicated.Nihon kohden replaced all the part(s) below and issue is resolved.9000006111a hard drive, 500gb, cns-6201 2 ea.All the malfunctioning part(s) were replaced.The unit was tested per the operator's/service manual.The unit completed 24 hours of extended testing and operates to the manufacturer's specifications.Investigation conclusion: the root cause is determined to be total loss of power at the facility, leading to improper shutdown of the cns and corruption of the hard drives.The issue was resolved upon replacing the hard drives and the unit was tested to operate within specifications.From the information available, the cns was operating within specifications, however became damaged as the specified operational power requirements were not met.Based on the information provided in the hazard analysis, operator's manual, and hha, the overall risk is low.Additional device information: d11 & c2: the following devices were being used in conjunction with the cns: transmitters: no model numbers and serial numbers were provided.Ups (3rd party device): no model and serial number was provided.Rns: no model and serial number was provided.

• 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: 9441072
• MDR Text Key: 200812027
• Report Number: 8030229-2019-00709
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921114131
• UDI-Public: 04931921114131
• Combination Product (y/n): N
• PMA/PMN Number: K102376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/19/2020

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/19/2020
• Distributor Facility Aware Date: 02/18/2020
• Device Age: 98 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/19/2020
• Initial Date Manufacturer Received: 11/18/2019
• Initial Date FDA Received: 12/09/2019
• Supplement Dates Manufacturer Received: 02/18/2020
• Supplement Dates FDA Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TRANSMITTERSUPSRNS; TRANSMITTERSUPSRNS