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

Model Number CSM-1702

Device Problems Application Program Problem (2880); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/28/2023

Event Type  malfunction  

Event Description

The biomedical engineer (bme) reported that the anesthesia technician was checking the nk unit prior to any surgical procedure in or and found that the g7 monitor freezes and was unable to use the touchscreen feature of the display monitor.They could not turn off the unit.Tech support (ts) walked them through doing the force shut down procedure by pressing check and service keys + power button while the ac power is unplugged.After forcing the shutdown, the unit was able to turn back on without any issues.Not in patient use and found at set-up.

Manufacturer Narrative

The biomedical engineer (bme) reported that the anesthesia technician was checking the nk unit prior to any surgical procedure in or and found that the g7 monitor freezes and was unable to use the touchscreen feature of the display monitor.They could not turn off the unit.Tech support (ts) walked them through doing the force shut down procedure by pressing check and service keys + power button while the ac power is unplugged.After forcing the shutdown, the unit was able to turn back on without any issues.Not in patient use and found at set-up.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 contains no information (ni), as attempts to obtain information were made, but the information was not provided.D10 concomitant medical device attempt #1 01/03/2024 emailed customer via microsoft outlook for all items under the no information section.The customer responded back with complaint details, but they did not provide the additional device information as requested.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the anesthesia technician found that the g7 monitor froze, causing the display's touchscreen feature to stop working when checking the device prior to a surgical procedure in the or.Additionally, they could not turn off the device.Technical support (ts) walked them through the process of performing a forced shutdown while the ac power was unplugged.The device powered back up with no issues.The device was not in patient use.Investigation summary: nihon kohden (nk) was able to confirm the reported issue.But based on the available information, the most probable root cause was potentially due to continuous multiple touch locations on the unit.This would cause confusion and overload the touch function on the screen causing the screen to freeze.As the device was not sent in for evaluation, and no logs were pulled for investigation, a definitive root cause could not be determined.Touch key issues occur when the touch position does not match the activated position, or when the touch functionality fails.Touch key response may also vary per user and may be affected by dirt, debris, or residual cleaner left on the screen.Users should note that, though the touchscreen has been designed to function for users wearing medical gloves, multiple gloves or other coverings may impede the touchscreen's functionality.Nk ts assisted the customer with the forced shutdown and the device booted back up and was working with no issues.A serial number review of the reported device (model: cu-172ra (g7), sn: (b)(6)) does not reveal additional related complaints.A complaint history review of the customer's account does not reveal trends for similar complaints.The following field contains no information (ni), as attempts to obtain information were made, but the information was not provided.Attempt #1 01/03/2024 emailed customer via microsoft outlook for all items under the no information section.The customer responded with complaint details, but did not provide the requested additional device information.

Event Description

The biomedical engineer (bme) reported that the anesthesia technician found that the g7 monitor froze, causing the display's touchscreen feature to stop working when checking the device prior to a surgical procedure in the or.Additionally, they could not turn off the device.The device was not in patient use.

• 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: 18585246
• MDR Text Key: 333825586
• Report Number: 8030229-2024-04046
• 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: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/10/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/28/2023
• Initial Date FDA Received: 01/25/2024
• Supplement Dates Manufacturer Received: 05/02/2024
• Supplement Dates FDA Received: 05/10/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/05/2022
• 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