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

Model Number CNS-6801A

Device Problems No Display/Image (1183); Display or Visual Feedback Problem (1184); Device Displays Incorrect Message (2591); Output Problem (3005)

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

Event Date 04/27/2023

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) received intermittent error messages of "registered bed not ready" for all the gz transmitters.The vitals and numerics would disappear, and the cns did not show comm loss on the tiles.No patient harm was reported.

Manufacturer Narrative

The biomedical engineer (bme) reported experiencing intermittent issues with the central nurse's station (cns) of a "registered bed not ready" error message for the gz transmitters.They said it affected different gz transmitters at varying times while monitoring patients.When the tile on the cns showed the error, the vitals and numerics would disappear, and the tile did not show a comm loss error.After 1 to 2 minutes, the error message would disappear, and they could see the patient's vitals and numerics.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.D10 concomitant medical device: the following device(s) were used in conjunction with the cns: gz transmitters: model #: ni.Serial #: ni.Device manufacturer data: ni.Unique identifier (udi) #: ni.Returned to nihon kohden: ni.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported experiencing intermittent issues with the central nurse's station (cns) of a "registered bed not ready" error message for the gz transmitters.They said it affected different gz transmitters at varying times while monitoring patients.When the tile on the cns showed the error, the vitals and numerics would disappear, and the tile did not show a comm loss error.After 1 to 2 minutes, the error message would disappear, and they could see the patient's vitals and numerics.No patient harm was reported.Investigation summary: on 05/04/2023, the customer stated they would check their network switches.On 05/30/2023, nk cits started running network packet captures (pcap) on the customer's local network environment and informed them to collect device information and logs if the issue recurs.Multiple follow-ups were sent to the customer, but they have been unresponsive.Nk cits also stated that they have had no updates since starting pcaps.A definitive root cause could not be determined since the issue has not been duplicated while observing the customer's network conditions.Since the gz transmitter relies on the customer's wireless network, a possible cause for this issue may be the condition of the customer's network environment.A possible cause has been identified from a similar complaint (ticket (b)(4) in which irc-144 was initiated to understand the "registered bed not ready" error message.From irc-144, nkc engineers stated that the "registered bed not ready" error message is displayed depending on the communication condition between the gz transmitter and cns.This error message will appear if the gz and cns have an established connection but are only able to communicate partial information to each other due to poor network conditions.In this case, it is recommended that the customer check the stability of their local network.D10 concomitant medical device: the following devices were used in conjunction with the cns: gz transmitters: 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 nurse's station (cns) received intermittent error messages of "registered bed not ready" for all the gz transmitters.The vitals and numerics would disappear, and the cns did not show comm loss on the tiles.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: 16969555
• MDR Text Key: 316509563
• Report Number: 8030229-2023-03540
• 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: 08/24/2023

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-6801A
• Device Catalogue Number: PU-681RA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2023
• Initial Date FDA Received: 05/19/2023
• Supplement Dates Manufacturer Received: 08/23/2023
• Supplement Dates FDA Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2022
• 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: GZ TRANSMITTERS; GZ TRANSMITTERS