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

Model Number CNS-6201A

Device Problems Communication or Transmission Problem (2896); Wireless Communication Problem (3283)

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

Event Date 07/24/2022

Event Type  malfunction  

Event Description

The customer reported that there were several central nurse's stations (cnss) showing comm loss.The cnss were monitoring a combination of bedside monitors (bsms) and telemetry transmitters.

Manufacturer Narrative

The customer reported that there were several central nurse's stations (cnss) showing comm loss.The cnss were monitoring a combination of bedside monitors (bsms) and telemetry transmitters.This issue occurred two other times and were reported on tickets (b)(4).There were no reports of power outages.The event logs indicate that the user was logged out of the nk required hostapp at 5:35am local time on the 172.16.10.8 host 1000 server.Logging the user back in resolved the issue.Nk ts asked if there were any pushed group policies, which would cause this issue, but the customer has not responded.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 Description

The customer reported that several central nurse's stations (cnss) were displaying comm loss.The cnss were monitoring a combination of bedside monitors (bsms) and telemetry transmitters.

Manufacturer Narrative

Details of complaint: the customer reported that several central nurse's stations (cnss) were displaying comm loss.The cnss were monitoring a combination of bedside monitors (bsms) and telemetry transmitters.This issue occurred two other times and were reported on tickets (b)(4).There were no reports of power outages.The event logs indicated that the user was logged out of the nk required hostapp at 5:35am local time on the 172.16.10.8 host 1000 server.Logging the user back in resolved the issue.Nihon kohden technical support (nk ts) asked if there were any pushed group policies, which would cause this issue, but the customer did not respond.No patient harm or injury was reported.Investigation summary: communication loss could delay the recognition and management of sudden deteriorations in vital signs or cardiac rhythm.Real-time monitoring would remain intact on bedside monitors and could still alert caregivers to changes in vital signs or heart rhythm.A "comm loss" error message would appear to alert clinicians to the issue in which alternate monitoring methods could be arranged.The root cause is determined to be related to the customer's it department.The customer's it team pushed a group policy order that logged out a hostapp user, resulting in the communication loss.There is no evidence of an nk device malfunction.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-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: 15276734
• MDR Text Key: 305420350
• Report Number: 8030229-2022-03064
• 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: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• 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: 02/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2014
• 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: MULTIPLE BSMS; MULTIPLE BSMS; MULTIPLE TRANSMITTERS; MULTIPLE TRANSMITTERS