MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CSM-1702; VITAL SIGNS MONITOR

Model Number CSM-1702

Device Problems Electrical /Electronic Property Problem (1198); Unexpected Shutdown (4019)

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

Event Date 02/14/2024

Event Type  malfunction  

Manufacturer Narrative

Biomedical engineer (bme) from the hospital reported that the g7 monitor has been powering down and then back up again on its own.Bme reported that the first time this occurred was on february 14th, the second time this occurred was on february 20th and then the issue occurred again on february 21st.Bme did not report the first two events to nihon kohden.No error messages were displayed.Bme is sending the device into nihon kohden for review of the event logs and testing of the device.There were no injuries 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 the obtain information were made, but not provided: attempt # 1: 02/27/2024 emailed the customer via microsoft outlook for all information in the ni list above: reply was received from biomedical engineer on 02/28/2024 requesting the return material number to return the device to nihon kohden and did not provide the requested information for fields a2-a6, b6-b7 and d10.

Event Description

Biomedical engineer (bme) from the hospital reported that the g7 monitor has been powering down and then back up again on its own.Bme reported that the first time this occurred was on february 14th, the second time this occurred was on february 20th and then the issue occurred again on february 21st.Bme did not report the first two events to nihon kohden.No error messages were displayed.Bme is sending the device into nihon kohden for review of the event logs and testing of the device.There were no injuries reported.

Manufacturer Narrative

Biomedical engineer (bme) from the hospital reported that the g7 monitor has been powering down and then back up again on its own.Bme reported that the first time this occurred was on february 14th, the second time this occurred was on february 20th and then the issue occurred again on february 21st.Bme did not report the first two events to nihon kohden.No error messages were displayed.Bme is sending the device into nihon kohden for review of the event logs and testing of the device.There were no injuries reported.Evaluation summary: during the investigation, the logs were unable to be obtained remotely.As a result, the unit was sent to our nihon kohden repair center to retrieve the logs as well as to perform some troubleshooting efforts.On 03/15/2024, the unit was cleaned and decontaminated.The model, serial number, and all labels were verified.The report ed problem (unit is boot looping) could not be duplicated.The unit was tested for over ninety hours with no issues or errors discovered.Our repair technician replaced the rpa-6121900503 assy front enclosure then the unit was tested per the operator's/service manual.Investigation summary: there was no history of the monitor restart at the date in the report from the customer.Additionally, there was no abnormal history.When turning on the monitor, the information whether the connection of the external display was recognized and shall be recorded in the log."ext touch: tps" means the history of the connection to the external display was recognized when starting the monitor."ext touch: discnct" means the history of the connection on the external display was not recognized when starting the monitor.The details are unknown since the log information of whether the connection of the external display was recognized shall not be recorded after starting the monitor.However, the connection of the external display was recognized for the first half of february 21st, 2024, while the connection of the external display was not recognized the second half.Therefore, the phenomenon in which the screen of the external display powered off then on again was explained as a restart.Based on the reported information, we were unable to confirm the customer's complaint and unable to determine a root cause.The front enclosure was replaced to prevent any underlying hardware/component issues with the unit; however, it was also recommended the customer update the ja-170p software version as it was discovered during the investigation the software version was not correct (possible compatibility issues).Updates may fail to download or install properly and create compatibility issues if the connection is interrupted or disconnected.Since the unit powered down then back up again with no error messages displayed it is likely an interruption or disconnection occurred from third-party application, system updates, or cable connection issues (loose or defective cables can occur through user error or physical damage from wear and tear); however, a definitive root cause could not be determined attempt # 1: 02/27/2024 emailed the customer via microsoft outlook for all information in the ni list above: reply was received from biomedical engineer on 02/28/2024 requesting the return material number to return the device to nihon kohden and did not provide the requested information for fields a2-a6, b6-b7 and d10.

Event Description

Biomedical engineer (bme) from the hospital reported that the g7 monitor has been powering down and then back up again on its own.Bme reported that the first time this occurred was on february 14th, the second time this occurred was on february 20th and then the issue occurred again on february 21st.Bme did not report the first two events to nihon kohden.No error messages were displayed.Bme is sending the device into nihon kohden for review of the event logs and testing of the device.There were no injuries reported.

• Brand Name: CSM-1702
• Type of Device: VITAL SIGNS MONITOR
• 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: 18915404
• MDR Text Key: 337799947
• Report Number: 8030229-2024-04186
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921004517
• UDI-Public: 04931921004517
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203435
• 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: 04/19/2024

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: CSM-1702
• Device Catalogue Number: CSM-1702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 03/15/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2021
• 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: NI.; NI.