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  

Event Description

The customer reported that this unit has had a vertical static bar like interference.There was no patient injury reported.

Manufacturer Narrative

The customer reported that this unit has had a vertical static bar like interference.The customer corrected the issue by shutting down the unit and unplugging the bedside monitor.According to the customer, they have never seen this issue until software 2-28 was installed.The technical service account manager will be uploading the logs.There was no patient injury 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.

• 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: 19209641
• MDR Text Key: 341493337
• Report Number: 8030229-2024-04229
• 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: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2024
• 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: 03/22/2022
• 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