MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CNS-9700A; CENTRAL MONITOR SYSTEM

Model Number CNS-9700A

Device Problem Connection Problem (2900)

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

Event Date 09/24/2021

Event Type  malfunction  

Manufacturer Narrative

The customer reported that they recently moved the central nurse's station (cns) from one side of the department to the other and when they went to connect/turn the cns back on, the unit displayed a network disconnect message.Technical support (ts) is working with the customer to troubleshoot the issue.There was no patient injury 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.

Event Description

The customer reported that the central nurse's station displayed a network disconnect message.There was no patient injury reported.

Manufacturer Narrative

Details of complaint: the customer reported that they recently moved the central nurse's station (cns) from one side of the department to the other and when they went to connect/turn the cns back on, the unit displayed a network disconnect message.Technical support (ts) is working with the customer to troubleshoot the issue.There was no patient injury reported.Investigation summary: based on the available information, a definitive root cause could not be identified.However, it is likely that the customer had not reconfigured the network settings of the cns to suit its new location.The cns was likely placed in a different network segment and would need its network settings to be reconfigured in order to connect to the network.The administrator's manual for the cns instructs users to configure the network settings of the device during installation.The customer likely had missed configuring the device during its installation on its new location.No corrective actions will be required at this time.Manufacturer references # (b)(4) follow up 001.

Event Description

The customer reported that the central nurse's station displayed a network disconnect message.There was no patient injury reported.

• Brand Name: CNS-9700A
• 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 ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa,, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 12684669
• MDR Text Key: 280205750
• Report Number: 8030229-2021-01848
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921000663
• UDI-Public: 04931921000663
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/19/2022

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-9700A
• Device Catalogue Number: MU-971RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/24/2021
• Initial Date FDA Received: 10/22/2021
• Supplement Dates Manufacturer Received: 06/20/2022
• Supplement Dates FDA Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2006
• 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