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

Model Number CNS-6201A

Device Problems No Display/Image (1183); Output Problem (3005); Unintended Application Program Shut Down (4032)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/04/2023

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the central nurses station (cns) shut down spontaneously, and after rebooting, one of the dual displays would not come back on.The patients were being monitored on the main display until the bme swapped out the cns with a spare 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 following fields contain no information (ni), as an attempt to obtain the information was made, but not provided.Attempt #1 (b)(6) 2023 called the bme for the patient information and the concomitant medical devices.The bme responded that they were unable to provide any details.Additional device information: d10 concomitant medical device: the following devices were used in conjunction with the cns: bsm(s): model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: na.Transmitter(s): model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: na.

Event Description

The biomedical engineer (bme) reported that the central nurses station (cns) shut down spontaneously, and after rebooting, one of the dual displays would not come back on.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the central nurses station (cns) shut down spontaneously, and after rebooting, one of the dual displays would not come back on.The patients were being monitored on the main display until the bme swapped out the cns with a spare unit.No patient harm was reported.Investigation summary: based on the available reported information, we confirmed the reported issue.A definitive root cause could not be determined as the device was not returned to the nihon kohden repair center for evaluation.However, it is highly likely the issue was due to wear and tear damage to the device and its internal components (due to aging and degradation over time), as the device was installed on 01/02/2013.The device is approximately 9 (nine) years and 9 (nine) months old.The expected useful life of the hard drive is about 20,000 hours of use and/or every two years.When spontaneous shutdowns occur and the device has aged, it indicates that components are failing, likely the hard disk drives (hdds) and/or computer boards or other internal components.Although a definitive root cause was not determined, we have identified some potential causes of the spontaneous shutdown/boot looping/hard drive issues.These events include user-related ungraceful exits and maintenance, or unexpected shutdowns, power outages, generator tests, uninterruptable power supply (failure) or power failure, and/or power surges.User-related setup/installation errors and/or software, network/connectivity/environmental/it issues, and software or file corruption a review of the device's historical data indicated (5) five complaints, including this issue, found in the past (3) three years.Three (3) of these were for separate issues regarding printer and time settings.One (1) issue was reported related to an hdd port 1 and port 2 issue, which indicated the hard drive was at or above the 20,000 hours of use.Based on the review of the complaint history for this device, no issues related to spontaneous shutdown were reported.A significant trend for the reported issue (spontaneous shutdown) and device has not been identified.The following fields contain no information (ni), as an attempt to obtain the information was made, but not provided.A2 - a6 b6 - b7 d10 attempt #1 07/06/2023 called the bme for the patient information and the concomitant medical devices.The bme responded that they were unable to provide any details.

Event Description

The biomedical engineer (bme) reported that the central nurses station (cns) shut down spontaneously, and after rebooting, one of the dual displays would not come back on.No patient harm was reported.

• 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 ; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 17436684
• MDR Text Key: 320169076
• Report Number: 8030229-2023-03687
• 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: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/17/2023

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
• Initial Date Manufacturer Received: 07/04/2023
• Initial Date FDA Received: 08/01/2023
• Supplement Dates Manufacturer Received: 10/09/2023
• Supplement Dates FDA Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2012
• 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: BSM(S); BSM(S); TRANSMITTER(S); TRANSMITTER(S)