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

Model Number CSM-1702

Device Problems Display or Visual Feedback Problem (1184); Image Display Error/Artifact (1304)

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

Event Date 04/01/2024

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported the g7 monitoring unit (g7) had vertical static waveforms during patient use.The bme instructed clinical staff to reboot the unit to resolve the issue.The bme was unable to duplicate the issue on a simulator.No patient harm was reported.The issue began after the software was upgraded to sw 02-28.Nk technical service account manager (tsam) pulled logs for nkc to review.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), an attempt to the obtain information was made, but not provided: a2 - a6.B6 - b7.D10.Attempt # 1: (b)(6) 2024 emailed the bme for all information in the ni list above: the bme replied that the unit was not connected to a cns and did not have any other information requested.

Event Description

The biomedical engineer (bme) reported the g7 monitoring unit (g7) had vertical static waveforms during patient use.There was no harm 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: 19151889
• MDR Text Key: 340872333
• Report Number: 8030229-2024-04247
• 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
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2024
• 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
• Date Manufacturer Received: 04/01/2024
• 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