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

Model Number	3600HR-00-1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ear Pain (4812)
Date of Event	04/28/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer reported that on a few occasions that the chamber pressure was pulsing/whooshing upon compression about 2.4 ata, with patient complaints of ear pain during treatment.The chamber has been evaluated by a sechrist trained technician and it was verified that the chamber was functioning as intended.The reported issue could not be replicated or confirmed.No issues were discovered that would confirm that the chamber was the cause of the patients experiencing barotrauma.Barotrauma is a minor inconvenience to patient that will resolve on its own or with minimal medical intervention.This report is being submitted soley in respone to a patient injury being reported as there was no issues discovered upon manufacturer evaluation of the suspected device.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 to sechrist that noted on a few occasions the chamber pressure pulsing/whooshing upon compression at 2.4 ata, with patient complaints of ear pain.

• Brand Name: SECHRIST INDUSTRIES INC.
• Common Device Name: CHAMBER, HYPERBARIC
• Manufacturer (Section D): SECHRIST INDUSTRIES INC.; 4225 e. la palma avenue; anaheim CA 92807
• Manufacturer Contact: victor arellano ; 4225 e. la palma avenue; anaheim, CA 92807 ; 7145798400
• MDR Report Key: 25088619
• Report Number: 2020676-2026-00006
• Device Sequence Number: 10574290
• Product Code: CBF
• UDI-Device Identifier: 00899660002123
• UDI-Public: 00899660002123
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 3600HR-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: 04/28/2026
• Initial Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2016
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown