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

Model Number CSM-1702

Device Problem Power Problem (3010)

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

Event Date 11/28/2023

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer (bme) reported that the g7 monitor was stuck in a blank black screen while monitoring patients.When the bme evaluated the unit, it was on and in the monitoring mode, when the bme went to power cycle it off, the unit would not power back on.The bme unplugged the power cable then plugged it back in and brought it back up, it was stuck on the power off screen (the pop up with the power buttons).The bme will send the unit in for evaluation and repair.There was no 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.

Event Description

The biomedical engineer (bme) reported that the g7 monitor was stuck in a blank black screen while monitoring patients.When the bme tested the unit, it was on and in the monitoring mode, when the bme went to power cycle it off, the unit would not power back on.The bme unplugged the power cable then plugged it back in and brought it back up, it was stuck on the power off screen (the pop up with the power buttons).The bme will send the unit in for evaluation and repair.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: 18369241
• MDR Text Key: 331073171
• Report Number: 8030229-2023-03948
• Device Sequence Number: 1
• Product Code: MHX
• 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: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2022
• 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