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

Model Number CNS-6201A

Device Problems Failure to Power Up (1476); Output Problem (3005); Power Problem (3010); Complete Loss of Power (4015)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/06/2021

Event Type  malfunction  

Event Description

The customer reported that their central nurse's station (cns) is displaying a "network disconnect error" after an ungraceful shutdown.No harm or injury was reported.When the power outage occurred, it force shutdown the cns.

Manufacturer Narrative

When the power outage occurred, it force shutdown the cns.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.

Event Description

The customer reported that the central nurse's station (cns) was displaying a "network disconnect error" message when trying to reboot the device after an ungraceful shutdown due to a power outage.No harm or injury was reported.

Manufacturer Narrative

Details of complaint: the customer reported that the central nurse's station (cns) was displaying a "network disconnect error" message when trying to reboot the device after an ungraceful shutdown due to a power outage.No patient harm was reported.Investigation summary: the cns application requires a network connection to initialize.The "network disconnect" message does not indicate a cns malfunction.Immediately prior to the "network disconnect" message, it was reported that there was an ungraceful shutdown - shutdown not according to the correct procedure.Examples of an ungraceful shutdown are, an incorrect procedure performed by the user, an abrupt power loss from a power outage, an ac outlet failure, a loose cable (environmental), and an unintended shutdown by the user.After performing the complete shutdown procedure, the user was able to resume patient monitoring.The cause of the ungraceful shutdown is undetermined based on the provided information.Service history for this serial is reviewed for any events leading up to the reported issue, and none were found.Subsequently, this cns needed hard drive replacement under ticket (b)(4) on 8/31/2021.Service history for this facility shows no environmental events leading up to the reported issue.

• Brand Name: CNS-6201A
• Type of Device: CENTRAL MONITOR SYSTEM
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; attn: shama mooman; 1-1 tajino; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; seibu bldg 2, 4th floor 1-11-2; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 12407922
• MDR Text Key: 282229736
• Report Number: 8030229-2021-01589
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921114131
• UDI-Public: 04931921114131
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1