MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CNS-6201A; CENTRAL MONITOR SYSTEM

Model Number CNS-6201A

Device Problems Display or Visual Feedback Problem (1184); Image Display Error/Artifact (1304); Output Problem (3005)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/07/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the central nurse's station (cns) was displaying a blue screen with error codes.The remote network station (rns) remained active and monitored the patients while the cns was down.The customer's on-call biomed tech was able to successfully reboot the device and have it back in operation about an hour after it initially failed.The nursing administration was notified of the down time.Nihon kohden tech support (nk ts) is examining the log files in an effort to determine the cause, and advised the customer to preemptively replace the computer and hard drives.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.Additional device information: the following devices were used in conjunction with the cns and were not the devices that experienced the failure.Transmitters - model: zm-521pa.S/n: (b)(4).Approximate age of the device: 66 months, device manufacturer date: 6/19/2014, unique identifier (udi) #: (b)(4).S/n: (b)(4).Approximate age of the device: 66 months, device manufacturer date: 6/19/2014, unique identifier (udi) #: (b)(4).S/n: (b)(4).Approximate age of the device: 66 months, device manufacturer date: 6/19/2014, unique identifier (udi) #: (b)(4).S/n: (b)(4).Approximate age of the device: 65 months, device manufacturer date: 7/19/2018, unique identifier (udi) #: (b)(4).S/n: (b)(4).Approximate age of the device: 61 months, device manufacturer date: 12/8/2014, unique identifier (udi) #: (b)(4).S/n: (b)(4).Approximate age of the device: 66 months, device manufacturer date: 6/19/2014, unique identifier (udi) #: (b)(4).S/n: (b)(4).Approximate age of the device: 66 months, device manufacturer date: 6/19/2014, unique identifier (udi) #: (b)(4).S/n: (b)(4).Approximate age of the device: 66 months, device manufacturer date: 6/19/2014, unique identifier (udi) #: (b)(4).S/n: (b)(4).Approximate age of the device: 66 months, device manufacturer date: 6/23/2014, unique identifier (udi) #: (b)(4).S/n: (b)(4).Approximate age of the device: 33 months, device manufacturer date: 3/24/2017, unique identifier (udi) #: (b)(4).S/n: (b)(4).Approximate age of the device: 66 months, device manufacturer date: 6/23/2014, unique identifier (udi) #: (b)(4).S/n: (b)(4).Approximate age of the device: 66 months, device manufacturer date: 6/26/2014, unique identifier (udi) #: (b)(4).S/n: (b)(4).Approximate age of the device: 66 months, device manufacturer date: 6/23/2014, unique identifier (udi) #: (b)(4).S/n: (b)(4).Approximate age of the device: 66 months, device manufacturer date: 6/23/2014, unique identifier (udi) #: (b)(4).S/n: (b)(4).Approximate age of the device: 66 months, device manufacturer date: 6/23/2014, unique identifier (udi) #: (b)(4).S/n: (b)(4).Approximate age of the device: 66 months, device manufacturer date: 6/12/2018, unique identifier (udi) #: (b)(4).S/n: (b)(4).Approximate age of the device: 66 months, device manufacturer date: 6/25/2014, unique identifier (udi) #: (b)(4).S/n: (b)(4).Approximate age of the device: 66 months, device manufacturer date: 6/25/2014, unique identifier (udi) #: (b)(4).S/n: (b)(4).Approximate age of the device: 10 months, device manufacturer date: 3/5/2019, unique identifier (udi) #: (b)(4).S/n: (b)(4).Approximate age of the device: 81 months, device manufacturer date:4/5/2013, unique identifier (udi) #: (b)(4).S/n: (b)(4).Approximate age of the device: 58 months, device manufacturer date: 2/9/2015, unique identifier (udi) #: (b)(4).S/n: (b)(4).Approximate age of the device: 18 months, device manufacturer date: 6/18/2018, unique identifier (udi) #: (b)(4).S/n: (b)(4).Approximate age of the device: 65 months, device manufacturer date: 7/4/2014, unique identifier (udi) #: (b)(4).S/n: (b)(4).Approximate age of the device: 65 months, device manufacturer date: 7/4/2014, unique identifier (udi) #: (b)(4).S/n: 00897 approximate age of the device: 65 months, device manufacturer date: 7/4/2014, unique identifier (udi) #: (b)(4).S/n: (b)(4).Approximate age of the device: 18 months, device manufacturer date: 6/11/2018, unique identifier (udi) #: (b)(4).S/n: (b)(4).Approximate age of the device: 65 months, device manufacturer date: 7/4/2014, unique identifier (udi) #: (b)(4).S/n: (b)(4).Approximate age of the device: 66 months, device manufacturer date: 6/11/2014, unique identifier (udi) #: (b)(4).S/n: (b)(4).Approximate age of the device: 100 months, device manufacturer date: 8/25/2011, unique identifier (udi) #: (b)(4).S/n: (b)(4).Approximate age of the device: 66 months, device manufacturer date: 6/19/2014, unique identifier (udi) #: (b)(4).S/n: (b)(4).Approximate age of the device: 65 months, device manufacturer date: 7/11/2014, unique identifier (udi) #: (b)(4).S/n: (b)(4).Approximate age of the device: 13 months, device manufacturer date: 11/28/2018, unique identifier (udi) #: (b)(4).

Event Description

The customer reported that the central nurse's station (cns) was displaying a blue screen with error codes.

Manufacturer Narrative

Details of complaint: the customer reported that the central nurse's station (cns) was displaying a blue screen with error codes.The remote network station (rns) remained active and monitored the patients while the cns was down.No patient harm or injury was reported.Investigation summary: the customer was able to successfully reboot the device and have it back in operation.The cns was down for approximately an hour.A review of the history of the serial number identified no further reports of the issue.Based on the available information, a definitive root cause could not be identified.Blue screen occurs when windows encounters a critical error that stops the operating system from running.This may be due to a hardware failure (i.E., hdd failure) and software failure (software corruption).The device's hardware may fail due to damage and wear and tear.

Event Description

The customer reported that the central nurse's station (cns) was displaying a blue screen with error codes.

• Brand Name: CNS-6201A
• 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 ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 9645163
• MDR Text Key: 209818168
• Report Number: 8030229-2020-00048
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921114131
• UDI-Public: 04931921114131
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102376
• 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: 01/29/2020,02/22/2023

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-6201A
• Device Catalogue Number: PU-621RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/29/2020
• Distributor Facility Aware Date: 01/07/2020
• Device Age: 65 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/29/2020
• Initial Date Manufacturer Received: 01/07/2020
• Initial Date FDA Received: 01/29/2020
• Supplement Dates Manufacturer Received: 02/20/2023
• Supplement Dates FDA Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2014
• 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: TRANSMITTERS; TRANSMITTERS