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

Model Number	3200
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspected device has not been evaluated by sechrist at this time eventhough we have reahced out to user to schedule service call.This report is based only on the information provided by user when reporting issue to sechrist.Once device is evaluated and root cause determined, a supplemental report will be submitted if needed.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 no.(b)(4).
Event or Problem Description
Customer reported that during pre-clinical check the chamber is falling outside the 120 second time frame to be in spec for the emergency venting.No patient involvement or patient/user injury reported.
Additional Manufacturer Narrative
The suspected device was evaluated by sechrist.The restrictor that controls the emergency decompression was replaced and the emergency decompression was confirmed to be in specification.The restrictor's failure is due to normal wear and tear.Manufacturer reference no.(b)(4).

• Brand Name: SECHRIST INDUSTRIES, INC.
• Common Device Name: HYPERBARIC CHAMBER
• 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: 23353006
• Report Number: 2020676-2025-00027
• Device Sequence Number: 8853761
• Product Code: CBF
• UDI-Device Identifier: 00852682007903
• UDI-Public: 00852682007903
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K950386
• 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,Followup
• Report Date (Section B): 12/09/2025

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: 3200
• 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: 09/25/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2009
• 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