MAUDE Adverse Event Report: SECHRIST INDUSTRIES SECHRIST INDUSTRIES INC.; CHAMBER, HYPERBARIC

Model Number	3300HR-00-1
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon inspection of the safety block, tech observed the safety pin would not fully retract during use, and also observed the chamber pressure indicator would not activate while pressurized.Rebuilt the safety interlock and chamber pressure indicator and verified full function.Device history record (dhr) review found no indication that there were any relevant discrepancies during manufacturing and found no non-conformance that could cause or contribute to the reported issue.The risk is mitigated to the lowest reasonable level through labeling and/or instructions in the user's manual.Sechrist recommends completing daily, weekly and semi-annual performance verification on the chamber to detect any issues and preclude the device from use.In instances where the chamber is found to function outside of specification, sechrist should be immediately notified for technical assistance.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.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).
Event or Problem Description
Customer reported the red chamber pressure indictor is not working and that also the door latch is getting stuck and not allowing the door to be opened.Issue was discovered during clinical check and there was no patient involvement.

• Brand Name: SECHRIST INDUSTRIES INC.
• Common Device Name: CHAMBER, HYPERBARIC
• 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: 23098678
• Report Number: 2020676-2025-00022
• Device Sequence Number: 18334379
• Product Code: CBF
• UDI-Device Identifier: 00899660002062
• UDI-Public: 00899660002062
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K140559
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2025

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: 3300HR-00-1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2012
• 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