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

Model Number	3600HR-01-1
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	Ear Pain (4812)
Date of Event	10/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer is reporting that the chamber is extremely slow to decompress at the end of the treatment and holding back residual pressure when the door is opened.Patient made complaint of ear pain when door was opened by staff.The chamber was evaluated by a trained sechrist technician, it was determined that the chamber was functioning as intended and within its specifications.The reported issue could not be confirmed.Therefore, the patient incident was not a result of the chamber not functioning properly.There is no evidence that a manufacturing non-conformity contributed to the reported complaint, and the instructions for use (ifu) were reviewed and determined to provide adequate instructions and warnings for the safe use of the device.Therefore, no corrective or preventive actions are necessary at this time.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 asessed, documented, and acted upon as warranted.Manufacturer reference file no.: (b)(4).
Event or Problem Description
Customer reported, "the chamber is extremely slow to decompress at the end of treatment and holding back residual pressure when the door is opened.Patient made complaint of ear pain when the door was opened by staff.".

• 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 (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: 20614469
• Report Number: 2020676-2024-00020
• Device Sequence Number: 8792489
• Product Code: CBF
• UDI-Device Identifier: 00899660002147
• UDI-Public: 00899660002147
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/05/2024

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: 3600HR-01-1
• 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: 10/15/2024
• Initial Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2013
• 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
• Patient Sex: Unknown