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

Model Number CNS-6201A

Device Problem Loss of Power (1475)

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

Event Date 11/17/2017

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the central nurse's station (cns) spontaneously shut down.He believed it was due to someone unplugging a connection in the network closet.He will check and call back if any additional help is needed.There has been no additional contact by the customer since the initial call.No patient harm 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 if additional information becomes available.

Event Description

The customer reported that the central nurse's station (cns) spontaneously shut down.

Event Description

The customer reported that the central nurse's station (cns) spontaneously shut down.

Manufacturer Narrative

Details of complaint: on 11/17/2017 customer reported device went down the previous night.Details on the issue was not provided.When customer rebooted the device, it came back up with the error "network disconnect" and went back to windows.Customer stated someone from the hospital was working on the network closet possibly unplugged or powered something off.Customer was working with their it department to find out what happened.Service requested: troubleshooting.Service performed: troubleshooting.Investigation result: when later contacted, customer stated the issue was resolved but was unable to provide details.The root cause could not be determined.Service history for this device shows the issue has not re-occurred.Service history for this customer shows one other incident of "network disconnect" error: ticket 24736.The root cause for this incident could not be determined.Correction: date of event.Aware populated instead of occurence date.Approximate age of device.Incorrectly calculated.

• 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: 7123760
• MDR Text Key: 95806755
• Report Number: 8030229-2017-00427
• 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: 08/29/2019

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/29/2019
• Distributor Facility Aware Date: 06/07/2019
• Device Age: 57 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/29/2019
• Initial Date Manufacturer Received: 12/15/2017
• Initial Date FDA Received: 12/15/2017
• Supplement Dates Manufacturer Received: 06/07/2019
• Supplement Dates FDA Received: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1