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

Model Number CNS-6801A

Device Problems No Display/Image (1183); Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)

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

Event Date 06/08/2023

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that central nurses station (cns) was not showing the ecg heart rate (hr) values when the transmitters were being used in hi-q view.However, the transmitters were showing the values.Bme resolved the issue by monitoring each transmitter by itself and changing the leads.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 attempts to obtain the information were made, but none were provided.A2 - a6 b6 b7 attempt #1 (b)(6) 2023 emailed bme for all items under the no information section and the concomitant medical devices.No reply was received.Attempt #2 (b)(6) 2023 emailed bme for all items under the no information section and the concomitant medical devices.The bme responded with the concomitant medical devices only.Additional device information: d10 concomitant medical devices: the following devices were used in conjunction with the cns: transmitter: model #: zm-531pa.Serial #: (b)(6).Device manufacturer data: 23/12/2021.Unique identifier (udi) #:(b)(4).Returned to nihon kohden: na.Org: model #: org-9110a.Serial #: (b)(6).Device manufacturer data: 26/08/2021.Unique identifier (udi) #:(b)(4).Returned to nihon kohden: na.

Event Description

The biomedical engineer (bme) reported that central nurses station (cns) was not showing the ecg heart rate (hr) values when the transmitters were being used in hi-q view.No patient harm was reported.

Manufacturer Narrative

Detail of complaint: the biomedical engineer (bme) reported that central nurse's station (cns) was not showing the electrocardiogram (ecg) or heart rate (hr) values when the transmitters were being used in hi-q view.However, the transmitters were showing the values.Bme resolved the issue by monitoring each transmitter by itself and changing the leads.No patient harm was reported.Investigation summary: as a result of the investigation, it was confirmed that the phenomenon could be reproduced when on the hiq-view function of the bedside monitor g5/g7.When switching the 6-electrode leads and the 3-electrode leads for the ecg of the zm transmitter, the g5/g7 operated to set the lead i to the chest leads (c1, c2).The correct behavior is to set one of the v1 to v6 leads for the chest leads (c1, c2).Although the customer reported that the hiq-view function was not used when the phenomenon of the 1st issue happened, it could not be identified from the log information because the log information didn't include the history of when the phenomenon happened.The cause was identified as the software of the g5/g7 monitoring unit when using the hiq-view function.Nkc plans to implement a countermeasure for the issue in the next g5/g7 monitor's software version, 02-27, estimated to be released in august 2023.To prevent the reoccurrence, update the g5/g7 monitors software once the countermeasure software is released.The issue will continue to be monitored and will be reassessed after the release of the next software version.Additional device information: d10 concomitant medical devices: the following devices were used in conjunction with the cns: transmitter: model #: zm-531pa.Serial #: (b)(6).Device manufacturer data: 23/12/2021.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: na.Org: model #: org-9110a serial #: (b)(6).Device manufacturer data: 26/08/2021.Unique identifier (udi) #: (b)(4).Returned to nihon kohden: na.G5 or g7 monitoring unit: (unknown which device was used) 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 central nurse's station (cns) was not showing the electrocardiogram (ecg) and heart rate (hr) values when the transmitters were being used in hi-q view.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: 17237591
• MDR Text Key: 318296916
• Report Number: 8030229-2023-03645
• 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: 08/08/2023

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: 06/08/2023
• Initial Date FDA Received: 06/30/2023
• Supplement Dates Manufacturer Received: 08/07/2023
• Supplement Dates FDA Received: 08/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2022
• 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: G5 MONITORING UNIT; G7 MONITORING UNIT; ORG; ORG; TRANSMITTERS; TRANSMITTERS