MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION CSM-1901; VITAL SIGNS MONITOR

Model Number CSM-1901

Device Problem Output Problem (3005)

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

Event Date 12/26/2023

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the g9 was getting a "system board failure sd" message.They transferred the patient to another unit to be monitored.Tech support (ts) helped them copy good settings from another unit onto a usb and transfers those to this failed g9.This resolved the issue.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.The following fields contains no information (ni), as attempts to obtain information were made, but the information was not provided.A2 - a6 b6 - b7 d10 concomitant medical device attempt #1 on (b)(6) 2023 emailed customer via microsoft outlook for all items under the no information section.They responded back with unknown to all questions.

Event Description

The biomedical engineer (bme) reported that the g9 was getting a "system board failure sd" message.They transferred the patient to another unit to be monitored.Tech support (ts) helped them copy good settings from another unit onto a usb and transfers those to this failed g9.This resolved the issue.No patient harm was reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the g9 monitor was getting a "system board failure sd" message.Technical support (ts) assisted with copying good settings from another g9 monitor onto a usb drive then transferring those to this failed g9 monitor.This resolved the issue.No patient harm was reported.Investigation summary: nihon kohden (nk) confirmed the issue was due to user related setup errors with the g9 device, (due to incorrect settings and the software needing to be reloaded), leading to a communication issue and the display of the error message, causing the reported issue.The nk ts technician provided troubleshooting and education to the customer, and confirmed the issue was resolved.No further issues were reported.There is no indication of improper or inadequate device design, as there has been no significant trend for this issue or any other reported issues with this device at the facility, in the past three (3) years.This was the only complaint found during the review, as such, this is an isolated incident and any further investigation, or any further corrective action, is not needed.Nk will continue to monitor trends for this device and facility for similar complaint issues.The following fields contains no information (ni), as an attempt to obtain the information was made, but not provided: a2 - a6 b6 - b7 d10 attempt #1 (b)(6) 2023 emailed customer via microsoft outlook for all items under the no information section.They responded that the requested information was unknown.Additional device information: d10 concomitant medical device: the following device was used in conjunction with the g9 monitor: bedside monitor (bsm): model #: bsm-1700 serial #: (b)(6).Additional information: b4 date of this report d10 concomitant medical device g3 date received by manufacturer g6 type of report h2 if follow-up, what type? h6 event problem and evaluation codes h11 additional manufacturer narrative.

Event Description

The biomedical engineer (bme) reported that the g9 monitor was getting a "system board failure sd" message.Technical support (ts) assisted with copying good settings from another g9 monitor onto a usb drive then transferring those to this failed g9 monitor.This resolved the issue.No patient harm was reported.

• Brand Name: CSM-1901
• 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: 18585176
• MDR Text Key: 333825706
• Report Number: 8030229-2024-04025
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04931921112168
• UDI-Public: 04931921112168
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151080
• 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: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CSM-1901
• Device Catalogue Number: CSM-1901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/02/2021
• 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: BSM