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	03/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The biomedical engineer (bme) reported that the central nurse's station (cns) will not boot up at all.They are getting an error that says disk failure.It will not boot up the bios or windows desktop.They have attempted to reboot, but it will turn on and the error appears right away.Tech support (ts) told the customer that this is a sunsetted product.It is no longer supported by phone or repair.Ts advised for them to upgrade this cns and to contact their local sales representative for a quote.They understood and asked for an end of life letter which was emailed to them.As the device was in patient use, qa inquired what happened to the unit prior to it not booting up, but they have been unresponsive.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 central nurse's station (cns) will not boot up at all.They are getting an error that says disk failure.It will not boot up the bios or windows desktop.They have attempted to reboot, but it will turn on and the error appears right away.Tech support (ts) told the customer that this is a sunsetted product.It is no longer supported by phone or repair.Ts advised for them to upgrade this cns and to contact their local sales representative for a quote.They understood and asked for an end of life letter which was emailed to them.As the device was in patient use, qa inquired what happened to the unit prior to it not booting up, but they have been unresponsive.No patient harm was reported.
Event or Problem Description
The biomedical engineer (bme) reported that the central nurse's station (cns) would not boot up and was giving a "disk failure" error message.No patient harm was reported.
Additional Manufacturer Narrative
Details of complaint: the biomedical engineer (bme) reported that the central nurse's station (cns) would not boot up and was giving a "disk failure" error message.Technical support (ts) advised the customer that this is a sunsetted product and is no longer supported by nk.Ts advised them to upgrade this cns and to contact their local sales representative for a quote.No patient harm was reported.Investigation summary: the device had been in service since 05/06/2011.There have been no other tickets on the device (sn: (b)(6) regarding start up failure.Mu-971ra is also a sunsetted product and is in end of service/ end of life.Based on the available information, a definitive root cause could not be identified.However, the device not booting up to bios or windows is a sign of hard disk drive (hdd) failure.Per the service manual for the cns-9701, it is recommended to replace the hdds every 2 years or 20,000 working hours.As the device is already sunsetted, nk no longer has parts to replace the hdds.If the hdd had not been replaced, a possible cause of the hdd failure is wear and tear.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.

• 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: 13984831
• Report Number: 8030229-2022-02751
• Device Sequence Number: 17634486
• 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): 05/03/2023

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: 03/04/2022
• Supplement Date Received by Manufacturer: 06/22/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2010
• 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