MAUDE Adverse Event Report: SECHRIST INDUSTRIES SECHRIST AIR/OXYGEN GAS MIXER 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	07/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned device found the alarm reed is touching the reed plate and not allowing the reed to vibrate and make sound.The returned device is due for routing service and likely root cause of the failure is normal wear and tear.The reported failure did not cause or contribute to serious injury or death.Since no systemic issue was determined, no corrective action is required at this time.At this time there is 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.The ifu states, "to ensure proper function and accuracy, the sechrist air/oxygen gas mixers must be thoroughly overhauled every two (2) years.To maintain the product warranty, the overhaul must be performed by sechrist industries or by sechrist authorized personnel." 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.Manufacturers reference file no.(b)(4).
Event or Problem Description
Customer reported the unit has no alarm when one of the supply lines is missing.This issue was discovered during set-up and there was no patient involvement.

• Brand Name: SECHRIST AIR/OXYGEN GAS MIXER 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; 4225 e. la palma ave.; anaheim CA 92807
• Manufacturer Contact: majid mashayekh ; 4225 e. la palma ave.; anaheim, CA 92807
• MDR Report Key: 22654861
• Report Number: 2020676-2025-00018
• Device Sequence Number: 21038528
• Product Code: DTX
• UDI-Device Identifier: 00899660002345
• UDI-Public: 00899660002345
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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: Foreign,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/29/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2018
• 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