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

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	02/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Emergency vent button was disassembled by si technician.Upon inspection of the emergency vent button, three way valve was sticking and not fully depressing when pushed.Part was swapped out by technician and emergency vent button reassembled.Chamber was then turned on and compressed.Emergency vent button tested and found to be working as designed.Chamber was taken to 30 psi and chamber fully decompressed in spec.Component wear determined to be the cause of issue.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
As reported by the customer, when doing weekly checks, noticed emergency vent button was not working properly.When button pushed and held down the decompression did not begin, instead had to push 4 or 5 times before decompression started.No patient involvement or injury reported.

• Brand Name: SECHRIST INDUSTRIES INC.
• Common Device Name: CHAMBER, HYPERBRIC
• 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: 21509616
• Report Number: 2020676-2025-00009
• Device Sequence Number: 7962788
• Product Code: CBF
• UDI-Device Identifier: 00852682007903
• UDI-Public: 00852682007903
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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
• Report Date (Section B): 02/28/2025

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: 3200-00
• 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: 02/03/2025
• Initial Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2010
• 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