MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC. SECHRIST INDUSTRIES, INC.; AIR/OXYGEN GAS MIXER

Model Number	3500CP-G
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer reported limited information about gas output issue intially.We have requested more information but have not recevied as of yet.This report is based soley on user reporting device not delivering set oxygen concentration.No patient injury reported.Device in question has not been evaluated by sechrist at this time.The device in question is past its service life and can no longer be serrviced by sechrist.Customer has been informed of this.At this time, the report is based on the information we have.We have requested more information from customer so we can complete investigation.The instructions for use were reviewed and found to provide adequate instructions for the safe and effective use of this device.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.Manufacturer reference file no.: (b)(4).
Event or Problem Description
Customer reporting, "the oxygen blender was not providing 100% oxygen, as it was set to, but a much lower fio2." no patient involvement or injury reported.No other information provided at this time.

• Brand Name: SECHRIST INDUSTRIES, INC.
• Common Device Name: AIR/OXYGEN GAS MIXER
• Manufacturer (Section D): SECHRIST INDUSTRIES, INC.; 4225 e. la palma avenue; anaheim CA 92807
• Manufacturer Contact: majid mashayekh ; 4225 e. la palma avenue; anaheim, CA 92807 ; 7145798400
• MDR Report Key: 22670049
• Report Number: 2020676-2025-00019
• Device Sequence Number: 11718596
• Product Code: DTX
• UDI-Device Identifier: 00899660002345
• UDI-Public: 00899660002345
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K023745
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 07/30/2025

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
• Operator of Device: Health Professional
• Device Model Number: 3500CP-G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/17/1992
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown