MAUDE Adverse Event Report: SECHRIST INDUSTRIES SECHRIST MONOPLACE HYPERBARIC CHAMBER MODEL 3600H/HR; CHAMBER, HYPERBARIC

Model Number	3600H/HR
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
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 device found chamber with door lock assembly unable to fully engage.Customer reported they do not remember checking the door arrow indicators were aligned or that the green safety pin was extracted at idle pressure before continuing with the pressure test at time of event.Chamber door top cap pin was found bent and in need of replacement in order to restore proper functioning of door lock system.Door swing arm assembly top cap was replaced, tested and verified to function as designed.Verified the door lock indicator functioned as expected.Pressurized chamber to 3 ata and found no faults in chamber function.Based on the service findings, the most probable root cause is that the chamber door was not securely closed before pressurizing the device.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).
Event or Problem Description
Customer reported the chamber door opened at 5 psi during daily startup and check.No patient injury was reported.Customer would like the chamber checked.

• Brand Name: SECHRIST MONOPLACE HYPERBARIC CHAMBER MODEL 3600H/HR
• 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
• MDR Report Key: 22835445
• Report Number: 2020676-2025-00021
• Device Sequence Number: 15687973
• Product Code: CBF
• UDI-Device Identifier: 00899660002079
• UDI-Public: 00899660002079
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/18/2025

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: 3600H/HR
• 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: 07/24/2025
• Initial Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2019
• 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