MAUDE Adverse Event Report: SECHRIST INDUSTRIES SECHRIST INDUSTIES; CHAMBER, HYPERBARIC

Model Number	3200-00
Medical Device Problem Code	Key or Button Unresponsive/not Working (4063)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Chamber was serviced by a field service technician, who confirmed the emergency valve did not function as designed.The emergency valve was replaced and chamber was verified to function as expected.The root cause is attributed to normal wear and tear of a mechanical component.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.Chambers are multi-use, serviceable items.As such, it is anticipated that the units may occasionally require repair, and as part of standard care the chambers should be inspected prior to use.If damage or functional issues are noted during these routine chamber inspections, the unit should not be put into use with a patient and should be reported to sechrist for servicing.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 emergency vent button is not working to perform emergency decompression test.Customer also reported the timing is out of spec for compression.No patient incident was reported.Issue was discovered at time of routine testing.

• Brand Name: SECHRIST INDUSTIES
• 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: 24048671
• Report Number: 2020676-2026-00002
• Device Sequence Number: 9421363
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/12/2026

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: 3200-00
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2010
• 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