MAUDE Adverse Event Report: SECHRIST INDUSTRIES INC. SECHRIST INDUSTRIES INC.; MIXER, BREATHING GASES, ANESTHESIA INHALATION

Model Number	3500CP-G24
Medical Device Problem Code	Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Eu distributor informing sechrist of mixer highly contaminated with blood and corrosion.No patient involvement or injury reported.Neither customer nor distributor reported to fda according to the information we have at this time.Device in question will not be evaluated by sechrist as eu distributor will evaluate.Eu distributor confirmed the device was contaminated with blood internally and corrosion present as well.At this time, the report is based on the information we have received from our eu distributor.Eu distributor concluded that user and error and improper cleaning of device to be the root cause.Sechrist has informed eu distributor that any devices that have been contaminated internally with blood or corrosion are to be decomissioned and not serviced.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
Eu distributor informing sechrist of mixer highly contaminated with blood and corrosison.No patient involvement or injury reported.

• Brand Name: SECHRIST INDUSTRIES INC.
• Common Device Name: MIXER, BREATHING GASES, ANESTHESIA INHALATION
• Manufacturer (Section D): SECHRIST INDUSTRIES INC.; 4225 e. la palma avenue; anaheim CA 92807
• Manufacturer (Section G): 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: 22820312
• Report Number: 2020676-2025-00020
• Device Sequence Number: 8756821
• Product Code: BZR
• UDI-Device Identifier: 00852682007491
• UDI-Public: 00852682007491
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K992503
• 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): 08/15/2025

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-G24
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/11/2016
• 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