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

Model Number CNS-6201A

Device Problem Output Problem (3005)

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

Event Date 10/27/2022

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the ecg waveforms disappear on two central nurse station's (cns) and then both of the cns's goes into communication loss.The bme reports this happens on all tiles on the two cns's in the er department.All tiles will lose the ecg waveforms, it will disappear quickly and then 5 seconds later it flickers and then it starts over again where it will take 20 to 30 seconds when the ecg waveform flickers and then it will happen 10 seconds later, occurring randomly.The bme rebooted the cns's involved but the issue remains, the bme did not know which ports the cns switches were on so the bme could not verify if there was an issue with the switches.No patient harm was reported.An mdr report 8030229-2022-03192 was filed on the cns pu-621ra s/n (b)(4) on complaint (b)(4).Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 if and or when additional information becomes available.The following fields contains no information (ni), as an attempt to obtain the information were made, but none were provided: patient information, relevant tests/lab data, other relevant history, and concomitant medical products and therapy dates.Attempt #1: 11/01/2022, emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 11/08/2022, emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3: 11/19/2022, emailed customer via microsoft outlook for all items under the no information section.No reply was received.

Event Description

The biomedical engineer (bme) reported that the ecg waveforms disappear on two central nurse station's (cns) and then both of the cns's goes into communication loss.The bme reports this happens on all tiles on the two cns's in the er department.All tiles will lose the ecg waveforms, it will disappear quickly and then 5 seconds later it flickers and then it starts over again where it will take 20 to 30 seconds when the ecg waveform flickers and then it will happen 10 seconds later, occurring randomly.The bme rebooted the cns's involved but the issue remains, the bme did not know which ports the cns switches were on so the bme could not verify if there was an issue with the switches.No patient harm was reported.An mdr report 8030229-2022-03192 was filed on the cns pu-621ra s/n (b)(4) on complaint (b)(4).

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the ecg waveforms would intermittently disappear, every 10-30 seconds on patient tiles at two central nurse's stations (cnss), in the er department then both cnss would go into comm loss.They tried rebooting both cnss, but the issue persisted.Another occurrence was reported two days prior in ticket (b)(4).No patient harm was reported.Investigation summary: the cns event logs were sent in for analysis.No issues or abnormalities were found during the analysis of the cns logs.Based on the logged events, it was concluded that the loss of monitoring was a result of issues with the hospital's network environment.Additional information could not be obtained from the customer and network captures could not be conducted as the customer was going to perform an upgrade of their enterprise gateway server.No further issues were reported for this event.A serial number review of the reported device reveals one prior occurrence that was also investigated by nkc.A complaint history review of the customer's account does not reveal similar complaints relating to these two events.An mdr report 8030229-2022-03192 was filed on the cns pu-621ra s/n (b)(6) on complaint (b)(4).Attempt #1 11/01/2022 emailed customer via microsoft outlook for all items in the ni list above.No reply was received.Attempt #2 11/08/2022 emailed customer via microsoft outlook for all items in the ni list above.No reply was received.Attempt #3 11/19/2022 emailed customer via microsoft outlook for all items in the ni list above.No reply was received.

Event Description

The biomedical engineer (bme) reported that the ecg waveforms would intermittently disappear, every 10-30 seconds on patient tiles at two central nurse's stations (cnss), in the er department then both cnss would go into comm loss.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; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 15834679
• MDR Text Key: 304025895
• Report Number: 8030229-2022-03198
• Device Sequence Number: 1
• Product Code: MHX
• 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: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• 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
• Date Manufacturer Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2015
• 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: NI.; NI.