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 09/01/2023

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that at the central nurse's station (cns) it was not showing the heart rate (hr) when a transmitter is being used in hi-q view.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.Additional device information: d10 concomitant medical device: the following device(s) were used in conjunction with the cns: transmitter: model #: zm-531pa, serial #: (b)(6), device manufacturer date: 12/23/2021, unique identifier (udi) #: (b)(4).

Event Description

The biomedical engineer (bme) reported that at the central nurse's station (cns) it was not showing the heart rate (hr) when a transmitter is being used in hi-q view.No patient harm was reported.

Manufacturer Narrative

Complaint details: the biomedical engineer (bme) reported that at the central nurse's station (cns) it was not showing the heart rate (hr) when a transmitter is being used in hi-q view.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).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.A2 - a6 b6 b7 attempt #1 09/21/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 09/22/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Additional device information: d10 concomitant medical device: the following device(s) were used in conjunction with the cns: transmitter model #: zm-531pa serial #: (b)(6).Device manufacturer data: 12/23/2021 unique identifier (udi) #: (b)(4).

Event Description

The biomedical engineer (bme) reported that at the central nurse's station (cns) it was not showing the heart rate (hr) when a transmitter is 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: 17814054
• MDR Text Key: 324232852
• Report Number: 8030229-2023-03784
• 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: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2023
• 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: TRANSMITTER; TRANSMITTER