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

Model Number	CNS-9700A
Medical Device Problem Codes	Application Program Problem (2880); Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the central nurse's station (cns) keeps inadvertently shutting down and coming back up.Also the arrhythmia is going in and out intermittently.Tech support (ts) informed the customer that the device is an end of life device and sounds like they are having hdd issues.They advised the customer to contact their nk representative to purchase a new device.Not in patient use.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 central nurse's station (cns) keeps inadvertently shutting down and coming back up.Also the arrhythmia is going in and out intermittently.Tech support (ts) informed the customer that the device is an end of life device and sounds like they are having hdd issues.They advised the customer to contact their nk representative to purchase a new device.Not in patient use.
Event or Problem Description
The biomedical engineer (bme) reported that the central nurse's station (cns) was in a boot loop.Additionally.The arrhythmia readings were going in and out intermittently.Not in patient use.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the central nurse's station (cns) was in a boot loop.Additionally.The arrhythmia readings were going in and out intermittently.Technical support (ts) informed the customer that the device was an end-of-life device.The device was not in patient use at the time.Investigation summary: ts informed the customer that the mu-971 model was an eos (end-of-service) device and had already been sunsetted.Nk noted that the issues the customer was experiencing were likely hdd issues.Based on the available information, the most probable cause of the issue is hdd failure.If the hdd of the device had not been replaced, it is likely that the hdd had failed due to wear and tear.Per the service manual for the mu-971ra, the expected life span of the hdd is 2 years (or 20,000 working hours), and it must be replaced periodically.The issue is likely due to a failure of a wear and tear component of the device.No corrective actions would be performed at this time.

• 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: 15811998
• Report Number: 8030229-2022-03170
• Device Sequence Number: 5501543
• Product Code: MHX
• UDI-Device Identifier: 04931921000663
• UDI-Public: 04931921000663
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/14/2023

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: 10/19/2022
• Supplement Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 11/17/2022
• Supplement Report FDA Received Date: 07/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2006
• 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