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

Model Number CNS-6201A

Device Problems Failure to Power Up (1476); Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2019

Event Type  malfunction  

Manufacturer Narrative

The customer reported that their hospital was conducting a generator test during which the central nurse's station (cns) went down and powered back on to a black screen.The customer also reported that the cns tower was powered on, but that the displays were black.The cns in question was plugged into a non-nihon kohden provided uninterruptible power supply (ups) at the time of the generator test.Nk ts advised the customer to swap the hard drives.The customer refused and requested to do an exchange of the entire unit instead.No harm or injury was reported.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.The following field contains no information (ni), as attempts to obtain information were made, but not provided: concomitant medical products.

Event Description

The customer reported that their hospital was conducting a generator test during which the central nurse's station (cns) went down and powered back on to a black screen.

Manufacturer Narrative

Details of complaint: on 11/13/2019 customer stated that a generator test caused the cns to shut down.Now cns device is showing a black screen.Cns device was plugged into hospital's ups at the time of generator test.During troubleshooting call with nk tech support, customer stated cns device shows bios screen but does not boot into windows.Nk tech support recommended customer in swapping the built-in raid hard drives to enable booting and raid rebuilding.Customer refused to swap the hard drives and requested an exchange.On 1/31/2020 customer stated they no longer need an exchange on the hard drive but did not provide details on the boot up issue.Investigation summary: the issue was reported after a power interruption at the hospital causing abrupt power loss to the cns device.Customer did not provide details on how the issue was resolved.Because the issue stemmed from an environmental factor, and moreover the redundant raid hard drives would enable customer to promptly swap out hard drives to resume monitoring.No capa is warranted at this time.Additional device information: the following field contains no information (ni), as attempts to obtain information were made, but not provided: d11 & c2 concomitant medical products.

Event Description

The customer reported that their hospital was conducting a generator test during which the central nurse's station (cns) went down and powered back on to a black screen.

• 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: 9419825
• MDR Text Key: 194966657
• Report Number: 8030229-2019-00703
• 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: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• 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?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/02/2020
• Distributor Facility Aware Date: 04/01/2020
• Device Age: 69 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/02/2020
• Date Manufacturer Received: 04/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability