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

Model Number CNS-9700A

Device Problems No Display/Image (1183); Display or Visual Feedback Problem (1184)

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

Event Date 06/17/2022

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) display monitor has a message appearing over the windows application stating "display settings failed, check display settings" interrupting the monitoring of the patients on the cns.The cns monitors transmitters.No patient harm or injury reported.Nihon kohden technical service agent had the bme check the resolution of the display monitor and found the resolution was incorrectly set and when the bme attempted to correct the setting, it would not accept the change.Nk technical service agent informed the bme this unit has reached the end of useful life and should be removed from use.

Manufacturer Narrative

The biomedical engineer (bme) reported that the central nurse's station (cns) monitor display has a message appearing over the windows application stating "display settings failed, check display settings" interrupting the monitoring of the patients on the cns.The cns monitors transmitters.No patient harm was reported.Nihon kohden technical service agent had the bme check the resolution of the display monitor and found the resolution was incorrectly set and when the bme attempted to correct the setting, it would not accept the change.Nihon kohden technical service agent informed the bme that this unit has reached the end of useful life and should be removed from use.Review of service history for the serial number of the device found no similar complaints reported.Based on the available information root cause is likely due to age of device and no history of prior complaints on this unit, therefore no corrective or preventative action is necessary.Concomitant medical products: attempt # 1: 07/01/2022 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 07/11/2022 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3: 07/13/2022 emailed the customer via microsoft outlook for patient information: no reply was received.

Event Description

The biomedical engineer (bme) reported that the monitor for the central nurse's station (cns) displayed a "display settings failed, check display settings" error message, which interrupted patient monitoring.No patient harm or injury reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the monitor for the central nurse's station (cns) displayed a "display settings failed, check display settings" error message, which interrupted patient monitoring.Technical support (ts) had the bme check the display resolution and found the resolution was set incorrectly.When the bme attempted to correct the setting, it would not accept the change.No patient harm was reported.Investigation summary: as no devices were returned for evaluation relating to this event, the reported issue could not be duplicated nor confirmed.As such, a root cause cannot be determined.Ts attempted troubleshooting the settings but could not clear the error or resolve the issue.The reported cns was installed at the customer's facility on (b)(6) 2007 and has been deemed at its end-of-life.The device has no previous history of repair or servicing.Due to the age of the device, the root cause is likely related to wear and tear due to aging.A serial number review of the reported device does not reveal additional related complaints.A complaint history review of the customer's account does not reveal trends for similar complaints.Nk will continue to monitor and trend similar complaints.Attempt # 1: 07/01/2022 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 2: 07/11/2022 emailed the customer via microsoft outlook for patient information: no reply was received.Attempt # 3: 07/13/2022 emailed the customer via microsoft outlook for patient information: no reply was received.

• 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 ; 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: 15004901
• MDR Text Key: 304554369
• Report Number: 8030229-2022-02978
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/13/2023

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: 06/17/2022
• Initial Date FDA Received: 07/13/2022
• Supplement Dates Manufacturer Received: 07/12/2023
• Supplement Dates FDA Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2006
• 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
• Treatment: ZM TRANSMITTERS.; ZM TRANSMITTERS.