MAUDE Adverse Event Report: SECHRIST INDUSTRIES INC. SECHRIST INDUSTRIES INC.; MIXER

Model Number	3500CP-G
Medical Device Problem Code	Gas Output Problem (1266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer reported issue to our eu distributor.No patient injury reported.Neither customer or distributor reported to fda according to the information we have at this time.Device in question will not be evaluated by sechrist as distributor will evaluate.At this time, the report is based on the information we have.We have requested more information from our distributor in regard to evaluation of device and service records of the device in question.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
Incident reported to sechrist by european distributor on 12/20/2024.Customer reporting that the mixer was not delivering gas.No patient injury was reported.

• Brand Name: SECHRIST INDUSTRIES INC.
• Common Device Name: 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: 21203726
• Report Number: 2020676-2025-00004
• Device Sequence Number: 19812531
• Product Code: DTX
• UDI-Device Identifier: 00899660002345
• UDI-Public: 00899660002345
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K023745
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/21/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/13/2020
• 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