MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CNS-6801A; CENTRAL MONITOR SYSTEM

Model Number CNS-6801A

Device Problems Communication or Transmission Problem (2896); Intermittent Communication Failure (4038)

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

Event Date 09/27/2023

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that central nurses station (cns) would display "please wait" when trying to admit six (6) bedside monitors (bsms) in the all beds screen.Once they rebooted the bsms and the cns, they re-monitored the affected bsms.However, the cns would un-monitor the bsms after five (5) minutes.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.Additional device information: d10 concomitant medical device: the following devices were used in conjunction with the cns; bsms.

Event Description

The biomedical engineer (bme) reported that central nurses station (cns) would display "please wait" when trying to admit six (6) bedside monitors (bsms) in the all beds screen.Once they rebooted the bsms and the cns, they re-monitored the affected bsms.However, the cns would un-monitor the bsms after five (5) minutes.No patient harm was reported.

Manufacturer Narrative

Details of the complaint: the biomedical engineer (bme) reported that central nurses station (cns) would display "please wait" when trying to admit six (6) bedside monitors (bsms) in the all beds screen.Once they rebooted the bsms and the cns, they re-monitored the affected bsms.However, the cns would un-monitor the bsms after five (5) minutes.No patient harm was reported.Investigation summary: a warranty exchange for the hard drive was sent to the customer.The customer also replied in a follow-up on 10/11/2023 that the issues were resolved after replacing the cpu.Although the complaint device was not returned for evaluation, the cause of these issues was most likely hardware component failure since these were resolved after component replacement.The hdds and cpu may fail due to physical damage or fluid intrusion from user mishandling, electrical damage from outages or surges, or wear-and-tear, which depends on the device's age and frequency of use.Hdd failure or corruption can also occur due to user error with file storage or ungraceful shutdown of the cns.A review of the complaint device's serial number shows 1 previous relevant complaint under ticket 165033 in which the cns froze, and the issue was resolved after rebooting the device.A definitive root cause for the issue under ticket (b)(4) could not be determined since we did not receive the device, but the issue may have been indicative of a hardware issue since the customer reported the cpu fans were spinning quickly before the cns froze.Overheating may contribute to the degradation of electronic components, and this can occur if there is a build-up of debris on the fan vents.The reported issues were resolved through component replacement and have not recurred.Nk will continue to monitor and trend similar complaints.

Event Description

The biomedical engineer (bme) reported that central nurses station (cns) would display "please wait" when trying to admit six (6) bedside monitors (bsms) in the all beds screen.Once they rebooted the bsms and the cns, they re-monitored the affected bsms.However, the cns would un-monitor the bsms after five (5) minutes.No patient harm was reported.

• Brand Name: CNS-6801A
• 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: 17999622
• MDR Text Key: 326512366
• Report Number: 8030229-2023-03827
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921131640
• UDI-Public: 04931921131640
• 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: 01/22/2024

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-6801A
• Device Catalogue Number: PU-681RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2023
• Initial Date FDA Received: 10/24/2023
• Supplement Dates Manufacturer Received: 01/18/2024
• Supplement Dates FDA Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2021
• 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: BSMS; BSMS