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

Model Number	CNS-9700A
Medical Device Problem Codes	Application Program Problem (2880); Application Program Freezes or Fails to Launch (4031)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The biomedical engineer (bme) reported that they had a generator test; and after it was done, the central nurse's station (cns) application on this unit does not come back up.They said that the unit is stuck on the windows screen, and the program will just blink and go away when they try to restart it.Tech support (ts) troubleshooted with the customer, and the issue persisted.Ts advised that this was an end of life device that could not be repaired.The customer stated they would replace it with a spare cns that they have.No patient harm was reported.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that they had a generator test; and after it was done, the central nurse's station (cns) application on this unit does not come back up.They said that the unit is stuck on the windows screen, and the program will just blink and go away when they try to restart it.Tech support (ts) troubleshooted with the customer, and the issue persisted.Ts advised that this was an end of life device that could not be repaired.The customer stated they would replace it with a spare cns that they have.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 when additional information becomes available.
Event or Problem Description
The biomedical engineer (bme) reported that the cns application on the central nurse's station (cns) would not load after a generator test.The cns was stuck at the windows screen when they tried rebooting the unit.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the cns application on the central nurse's station (cns) would not load after a generator test.The cns was stuck at the windows screen when trying to reboot the unit.Technical support (ts) attempted to troubleshoot the issue, but the issue persisted.Ts advised that this was an end-of-life device that could not be repaired.The customer stated they would replace it with a spare cns to continue patient monitoring.No patient harm was reported.Investigation summary: ts informed the customer that the device is in end of service, and nk no longer repairs this device.The device had been in service since 06/11/2006.A review of the history of the serial number identified no similar events.Based on the available information, a definitive root cause could not be identified.Possible causes of the issue are software corruption and wear and tear from normal use.A definitive root cause could not be determined, and the issue involves a discontinued device.

• Brand Name: CNS-9700A
• Common Device Name: 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: 13466876
• Report Number: 8030229-2022-02446
• Device Sequence Number: 4826076
• Product Code: MHX
• UDI-Device Identifier: 04931921000663
• UDI-Public: 04931921000663
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K023475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2023

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2022
• Supplement Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 02/05/2022
• Supplement Report FDA Received Date: 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2006
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown