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

Model Number	CNS-9700A
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The biomedical engineer (bme) reported that the central nurse's station (cns) was not displaying the waveforms for one of the bedside monitor (bsm) that was being monitored on it.The numerics display, but the waveforms are not.This is an end of life device, and tech support (ts) advised them to replace the unit.No patient harm was reported.
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the central nurse's station (cns) was not displaying the waveforms for one of the bedside monitor (bsm) that was being monitored on it.The numerics display, but the waveforms are not.This is an end of life device, and tech support (ts) advised them to replace the unit.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.The customer responded back with complaint details, but they did not provide the patient and device information as requested.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the central nurse's station (cns) was not displaying the waveforms for one of the bedside monitors (bsm) being monitored on it.The numerics displayed, but the waveforms were not.No patient harm was reported.Investigation summary: further information was not provided.There were no reports of communication loss or signal loss with the event.This is indicative of performance issue related to the cns device having been up for too long.The operator's manual states to perform a system reboot once every three months to ensure proper performance.The reboot clears and refreshes the memory to ensure adequate system resources for patient monitor.A service history review of this serial number shows this is an isolated incident.The probable cause is lack of routine maintenance.There is no evidence of a device malfunction.There was no recurrence of the issue.The following fields contains no information (ni), as attempts to obtain information were made, but not provided.Attempt #1 (b)(6) 2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 (b)(6) 2022 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 (b)(6) 2022 emailed customer via microsoft outlook for all items under the no information section.The customer responded with complaint details, but did not provide the requested information.Additional information: b4 date of this report.G3 date received by manufacturer.G6 type of report.H2 if follow-up, what type? h6 event problem and evaluation codes.H10 additional manufacturer narrative.
Event or Problem Description
The biomedical engineer (bme) reported that the central nurse's station (cns) was not displaying the waveforms for one of the bedside monitors (bsm) being monitored on it.The numerics displayed, but the waveforms were not.No patient harm was reported.

• 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: 15902317
• Report Number: 8030229-2022-03208
• Device Sequence Number: 5298313
• Product Code: MHX
• UDI-Device Identifier: 04931921000663
• UDI-Public: 04931921000663
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 07/20/2023

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: 11/01/2022
• Supplement Date Received by Manufacturer: 04/03/2023
• Initial Report FDA Received Date: 12/02/2022
• Supplement Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2009
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NI.; NI.
• Patient Sex: Unknown