MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC SECHRIST 3600H/HR HYPERBARIC OXYGEN CHAMBER; CHAMBER, HYPERBARIC

Model Number 3600H/HR

Device Problem Fail-Safe Problem (2936)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/17/2021

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the device found the emergency vent was out of specification and taking longer than 120 seconds to reach the surface from 3 ata.Upon inspection of the chamber the ideal pressure regulator cap was slightly loose, also causing the chamber, during use, to decompress back to the surface without stopping at idle pressure and returning to the surface when the chamber was still running.Performed a visual internal inspection of the idle pressure regulator, reassembled and adjusted idle pressure to 1.5 psi at a rate of three of 275 lpm.Chamber was re-pressurized back to 3 ata and emergency decompression test was performed.Chamber was found to be in spec with a time of 93 seconds to open door.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 Description

Customer reported the emergency vent button is not working during weekly test, but the emergency toggle switch will work and is in spec, chamber is still in service.No patient incident was reported.

• Brand Name: SECHRIST 3600H/HR HYPERBARIC OXYGEN CHAMBER
• 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: 11440971
• MDR Text Key: 238940177
• Report Number: 2020676-2021-00004
• Device Sequence Number: 1
• Product Code: CBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140559
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3600H/HR
• Device Catalogue Number: 3600H/HR
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2011
• 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