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

Model Number	3300H-00
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Burn(s) (1757); Insufficient Information (4580)
Date of Event	01/31/2025
Type of Reportable Event	Death
Event or Problem Description
On january 31, 2025, sechrist became aware of a death, to a child, that was being treated in a hyperbaric chamber.Officials in (b)(6), michigan confirmed a child died after the incident.
Additional Manufacturer Narrative
This report is based solely on the available information at this time.This incident is currently under investigation by the (b)(6), michigan officials and sechrist has not yet been officially notified.At this time, there is not enough information to determine the root cause or if any device malfunction occured.Manufacturer reference file no: (b)(4).
Additional Manufacturer Narrative
This will supplement the information submitted on january 31, 2025 (same day of the incident), (b)(6) 2025 regarding the incident that incurred at (b)(6) in (b)(6), involving a sechrist model 3300hr hyperbaric chamber identified by s/n (b)(6).On june 26, 2025, a representative of sechrist attended an inspection of the sechrist model 3300hr hyperbaric chamber identified by s/n (b)(6).The inspection was attended by counsel representing individuals against whom criminal charges have been filed in the state of michigan.The inspection was attended by counsel representing the (b)(6) family, the (b)(6) center and the property owner / manager, the city of (b)(6) (civil parties).The inspection was attended by consultants retained by the parties.The inspection was conducted pursuant to a june 23, 2025 order of the honorable (b)(6) in the circuit court for the county of (b)(6) (case no (b)(6)) that lifted a prior restraining order on the premises and permitted the inspection.Representatives of the (b)(6) fire department hosted the inspection.The consultants retained by the parties took photos of the incident scene and subject sechrist model 3300hr hyperbaric chamber.The inspection included 3d scans of the incident scene and portions of the sechrist model 3300hr hyperbaric chamber.The inspection included testing of the grounding of the subject sechrist model 3300hr hyperbaric chamber and testing of the circuits in the subject sechrist model 3300hr hyperbaric chamber.Sechrist representative did not identify any evidence that there was a grounding strap in the subject at the time of the incident.Sechrist representative conducted the testing of the circuits of the subject sechrist model 3300hr hyperbaric chamber.Sechrist representative did not identify anything wrong with any of the circuits of the subject sechrist model 3300hr hyperbaric chamber.The subject sechrist model 3300hr hyperbaric chamber and artifacts from the incident including the stretcher plate and textiles on the stretcher plate are being preserved by the parties for future lab testing pursuant to a protocol to be agreed upon.Manufacturer reference file no.: (b)(6).

• Brand Name: SECHRIST INDUSTRIES INC.
• Common Device Name: CHAMBER, HYPERBARIC
• Manufacturer (Section D): SECHRIST INDUSTRIES INC.; 4225 e. la palma ave.; anaheim 92807
• Manufacturer (Section G): SECHRIST INDUSTRIES INC.; 4225 e. la palma ave.; anaheim CA 92807
• Manufacturer Contact: majid mashayekh ; 4225 e. la palma ave.; anaheim 92807
• MDR Report Key: 21289171
• Report Number: 2020676-2025-00007
• Device Sequence Number: 21214819
• Product Code: CBF
• UDI-Device Identifier: 00852682007637
• UDI-Public: 00852682007637
• Combination Product (Y/N): N
• PMA/510(K) Number: K140559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

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: 3300H-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2013
• 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: Death
• Patient Age: 5 YR
• Patient Sex: Male