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

Model Number CNS-6801A

Device Problems Data Problem (3196); Patient Data Problem (3197)

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

Event Date 05/09/2023

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that the central nurse's station (cns) is showing an arryhthmia analysis off error, when the error happens the bme technician has to physically turn the arrythmia analysis back on.This is happening while the patient is being monitored however, no patient harm was reported.Nihon kohden technician had the bme technician check the alarm master settings, all settings in the alarm master, arryhthmia alarm are set correctly.Nihon kohden technician requested the bme technician to send in logs for the times of the events for further investigation.

Manufacturer Narrative

The biomedical engineer (bme) reported that the central nurse's station (cns) is showing an arryhthmia analysis off error, when the error happens the bme technician has to physically turn the arryhthmia analysis back on.This is happening while the patient is being monitored however, no patient harm was reported.Nihon kohden technician had the bme technician check the alarm master settings, all settings in the alarm master, arryhthmia alarm are set correctly.Nihon kohden technician requested the bme technician to send in logs for the times of the events for further investigation.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 biomedical engineer (bme) reported that the central nurse's station (cns) is showing an arryhthmia analysis off error, when the error happens the bme technician has to physically turn the arrythmia analysis back on.This is happening while the patient is being monitored however, no patient harm was reported.Nihon kohden technician had the bme technician check the alarm master settings, all settings in the alarm master, arryhthmia alarm are set correctly.Nihon kohden technician requested the bme technician to send in logs for the times of the events for further investigation.

Manufacturer Narrative

Datails of complaint: the biomedical engineer (bme) reported that the central nurse's station (cns) is showing an arryhthmia analysis off error, when the error happens the bme technician has to physically turn the arryhthmia analysis back on.This is happening while the patient is being monitored however, no patient harm was reported.Nihon kohden technician had the bme technician check the alarm master settings, all settings in the alarm master, arryhthmia alarm are set correctly.Nihon kohden technician requested the bme technician to send in logs for the times of the events for further investigation.Investigation summary: multiple follow-up attempts were done to gather more information and retrieve the device logs, but the customer has been unresponsive.A definitive root cause could not be determined since the complaint could not be confirmed.The operator's manual states that when using multiple devices, the user should ensure default alarm settings (alarm master) are the same across a department/facility.Wireless communication issues can occur due to the customer's local network or environmental interference from other radio-emitting devices on the customer site.Hardware component issues with the main board of the telemetry device may affect its ability to hold settings.This can occur due to physical damage or fluid intrusion from user mishandling, power issues from improper battery use/insertion, or wear-and-tear which depends on device age and frequency of use.General handling instructions for telemetry devices are listed in their operator's manuals.Review of the complaint device's serial number does not show any recurrence or other similar complaints.The following fields contains no information (ni), as an attempt to obtain the information were made, but none were provided.A2 - a6 b6 b7 d10 attempt #1 05/31/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #2 06/02/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.Attempt #3 06/05/2023 emailed customer via microsoft outlook for all items under the no information section.No reply was received.

• 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: 17063214
• MDR Text Key: 317456202
• Report Number: 8030229-2023-03585
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/05/2023

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: 05/09/2023
• Initial Date FDA Received: 06/05/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/05/2023
• 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