MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC SECHRIST HYPERBARIC OXYGEN CHAMBER MODEL 3300H; CHAMBER, HYPERBARIC

Model Number 3300H

Device Problem Decrease in Pressure (1490)

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

Event Date 06/17/2022

Event Type  malfunction  

Event Description

Customer reported ,the door gasket, during treatment at 2.4ata had blown out of the gasket seat, causing the chamber to loose all chamber pressure during use.Customer states no injury occurred to the patient.

Manufacturer Narrative

Inspection of the chamber, after the incident, found the handle was bent, the pin stop in cam hinge cover was bent and the door gasket was not installed in chamber but was ok.On the lower hinge cover there was a nick and scratch indicating the safety pin had not engaged properly in the hinge cover.The ifu warns "always verify that the swing arm lever is pushed as far as it will go.A slight sound will be heard.Always push the swing arm lever firmly until it stops." service repair replaced all damaged parts and verified the safety pin engaged properly and certified the chamber for patient use.The customer was made aware of the possible cause for the reported issue and instructed to check that the safety pin is fully engaged at ~2psi.A dhr review found no evidence that a manufacturing non-conformity contributed to the reported complaint.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).

• Brand Name: SECHRIST HYPERBARIC OXYGEN CHAMBER MODEL 3300H
• 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: 14950977
• MDR Text Key: 304180227
• Report Number: 2020676-2022-00018
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/07/2022

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
• Device Operator: Health Professional
• Device Model Number: 3300H
• Device Catalogue Number: 3300H
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2022
• Initial Date FDA Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2012
• 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): Required Intervention
• Patient Sex: Male