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

Model Number CNS-6801A

Device Problems No Display/Image (1183); Data Problem (3196)

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

Event Date 08/11/2023

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that the transmitter device (s) were not showing the heart rate (hr) when placed in hi-q view on the central nurse's station (cns).No patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the transmitter device(s) were not showing the heart rate (hr) when placed in hi-q view on the central nurse's station (cns).No patient harm was reported.Investigation summary: the investigation 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).The cause was identified as the software of the g5 monitoring unit when using the hiq-view function.Nkc plans to implement a countermeasure for the issue in the next g5 monitor's software version, 02-27, estimated to be released in august 2023.To prevent the reoccurrence, update the g5 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 device: the following device(s) were used in conjunction with the cns: model #: zm-530pa.Serial #: ni.Device manufacturer data: (b)(4).Unique identifier (udi) #: (b)(4).

Event Description

The biomedical engineer (bme) reported that the transmitter device was not showing the heart rate (hr) when placed in hi-q view on the central nurse's station (cns).No patient harm was reported.

Manufacturer Narrative

Complaint details: the biomedical engineer (bme) reported that the transmitter device was not showing the heart rate (hr) when placed in hi-q view on the central nurse's station (cns).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.The correct behavior is to set one of the v1 to v6 leads for the chest leads (c1, c2).This issue was investigated by nkc in which the root cause was found to be a software deficiency for the g5/g7 monitor viewing the zm transmitter in hi-q view.Countermeasures were added to g5/g7 software version 02-27 to address the issue.According to nihon kohden technical service account manager (nk tsam), the issue was resolved after the g5/g7 software update to versions 02-27.The following fields contains no information (ni), as an attempt to obtain the information were made, but none were provided.Attempt #1 08/15/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 08/17/2023 emailed customer via microsoft outlook for all items under the no information section.Reply was received, and the biomed only provided the concomitant medical device model(s) involved were (3) zm-531pa but did not provide the serial number(s) and stated "i do not have any of the patient demographic information.Additional device information: d10 concomitant medical device: the following device(s) were used in conjunction with the cns: model #: zm-530pa serial #: ni device manufacturer data: ni unique identifier (udi) #: (b)(4).

• 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: 17726383
• MDR Text Key: 323443778
• Report Number: 8030229-2023-03756
• 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: 09/11/2023
• 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
• Date Manufacturer Received: 12/06/2023
• 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: ZM TRANSMITTER; ZM TRANSMITTER