MAUDE Adverse Event Report: SECHRIST INDUSTRIES SECHRIST AIR/OXYGEN GAS BLENDER MODEL 3500CP-G; GAS CONTROL UNIT, CARDIOPULMONARY BYPASS

Model Number	3500CP-G
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported the unit does not alarm when it is disconnected from air or o2.No patient incident was reported.
Additional Manufacturer Narrative
This report is based solely on the customer's reported issue.The device was returned to sechrist for evaluation but has not yet been evaluated.A dhr review found no evidence that a manufacturing non-conformity contributed to the reported complaint, and the instructions for use were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device.Therefore, no corrective or preventative actions are necessary.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).
Additional Manufacturer Narrative
When the initial report was submitted, the device in question had not been evaluated by sechrist.The device has been evaluated and determined that a component of the device caused the reported issue due to premature wear.The component was replaced and the device was tested and verified to be functioning to specifications.The device was returned to customer and no complaints have been received since repair in regards to alarm not sounding.

• Brand Name: SECHRIST AIR/OXYGEN GAS BLENDER MODEL 3500CP-G
• Common Device Name: GAS CONTROL UNIT, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SECHRIST INDUSTRIES; 4225 e. la palma ave.; anaheim CA 92807
• Manufacturer (Section G): SECHRIST INDUSTRIES INC.; 4225 e. la palma ave.; anaheim CA 92807
• Manufacturer Contact: majid mashayekh ; 4225 e. la palma ave.; anaheim, CA 92807
• MDR Report Key: 21868146
• Report Number: 2020676-2025-00013
• Device Sequence Number: 7888666
• Product Code: DTX
• UDI-Device Identifier: 00899660002345
• UDI-Public: 00899660002345
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3500CP-G
• Device Catalogue Number: 3500CP-G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2024
• 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