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

Model Number CSM-1901

Device Problems Defective Device (2588); Output Problem (3005)

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

Event Date 07/15/2021

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the g9 monitor was giving a "system board failure conn" and multilink configuration error messages while in use on a patient.The patient was transferred to a different device so that the bme could troubleshoot the issue which was resolved by replacing the micro stream pod kit.There was no patient harm 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.Attempt # 1: (b)(6) 2021 emailed the customer via microsoft outlook for all items under the no information section.No reply was received.Attempt # 2: (b)(6) 2021 emailed the customer via microsoft outlook for all items under the no information section.No reply was received.Attempt # 3: (b)(6) 2021 emailed the customer via microsoft outlook for all items under the no information section.No reply was received.Additional device information: concomitant medical device: the following device(s) were being used in conjunction with the g9 unit, but model and serial number information was noted as no information (ni) , as attempts to obtain information were made.No reply was received.Micropod.Model #: ni, serial #: ni, device manufacturer data: ni, unique device identifier (udi) #: ni.

Event Description

The biomedical engineer (bme) reported that the g9 monitor was giving a "system board failure conn" and multilink configuration error messages while in use on a patient.The patient was transferred to a different device so that the bme could troubleshoot the issue which was resolved by replacing the micro stream pod kit.There was no patient harm reported.

Manufacturer Narrative

Details of complaint: the biomedical engineer (bme) reported that the core unit (g9 monitor) was giving "system board failure conn" and "multilink configuration" error messages while in use with a patient.The patient was transferred to a different device so the bme could troubleshoot the issue, which was resolved by replacing the micropod.No patient harm was reported.Investigation summary: the reported issue of g9 monitor displaying a system board failure was confirmed during troubleshooting with the customer.The system board failure indicates an abnormality in the system board's voltage or internal communication.The error populated when the customer plugged in a micropod etco2 unit.The micropod was removed, and the error did not populate.As such, the cause of the error was the use of a defective micropod.As the micropod was not returned for evaluation, the reported issue could not be duplicated nor confirmed.As such, a root cause cannot be determined.Hardware failure could come as a result of physical damage, heat damage, or electrical damage.Physical damage could occur due to impacts with objects and other surfaces.Heat damage could occur due to improper maintenance or placement.Electrical damage could occur during a power outage or power surge.Wear and tear due to aging or frequency of use can gradually degrade components.There is no significant trend regarding the issue.Nk will continue to trend and monitor the reported issue.The following fields contain no information (ni), as attempts to obtain information were made, but none was provided.Attempt # 1: (b)(6) 2021 emailed the customer via microsoft outlook for all items under the no information section.No reply was received.Attempt # 2: (b)(6) 2021 emailed the customer via microsoft outlook for all items under the no information section.No reply was received.Attempt # 3: (b)(6) 2021 emailed the 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 was being used in conjuction with the g9 monitor, but model and serial number information was noted as no information (ni) , as attempts to obtain information were made.No reply was received.Micropod.Model #: ni.Serial #: ni.Device manufacturer data: ni.Unique device identifier (udi) #: ni.Additional information: b4 date of this report.G3 date received by manufacturer.G6 type of report.H2 if follow-up, what type? h6 event problem and evaluation codes.H10 additional manufacturer narrative.

Event Description

The biomedical engineer (bme) reported that the core unit (g9 monitor) was giving "system board failure conn" and "multilink configuration" error messages while in use with a patient.The patient was transferred to a different device so the bme could troubleshoot the issue, which was resolved by replacing the micropod.There was no patient harm 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; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 12304892
• MDR Text Key: 266033920
• Report Number: 8030229-2021-01466
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/22/2023

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: CSM-1901
• Device Catalogue Number: CSM-1901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/15/2021
• Initial Date FDA Received: 08/10/2021
• Supplement Dates Manufacturer Received: 05/22/2023
• Supplement Dates FDA Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2016
• 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: MICROPOD; MICROPOD