MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC. SECHRIST INDUSTRIES, INC. MONOPLACE HYPERBARIC CHAMBER - MODEL 4100H/HRCHAMBER; CHAMBER, HYPERBARIC

Model Number 4100H/HR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Event Date 01/25/2023

Event Type  Injury  

Manufacturer Narrative

This report is soley for the reported issue that a patient experienced a barotrauma during treatment.Upon inspection of chamber, sechrist trained technician could not replicate the reported failure.The chamber testing revealed that the chamber is functioning as intended and within its specifications.At this time, 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 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 asessed, documented, and acted upon as warranted.Manufacturer reference file no.(b)(4).

Event Description

During treatment, customer found that the chamber was running too fast.Caused barotrauma to patient.

• Brand Name: SECHRIST INDUSTRIES, INC. MONOPLACE HYPERBARIC CHAMBER - MODEL 4100H/HRCHAMBER
• Type of Device: CHAMBER, HYPERBARIC
• Manufacturer (Section D): SECHRIST INDUSTRIES, INC.; 4225 e. la palma ave.; anaheim CA 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, CA 92807 ; 7145798309
• MDR Report Key: 16269308
• MDR Text Key: 308441563
• Report Number: 2020676-2023-00002
• Device Sequence Number: 1
• Product Code: CBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4100H/HR
• Device Catalogue Number: 4100H/HR
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other