MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC. SECHRIST MONOPLACE HYPERBARIC CHAMBER -MODEL 3200; CHAMBER, HYPERBARIC

Model Number 3200

Device Problem Decrease in Pressure (1490)

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

Event Date 09/26/2022

Event Type  malfunction  

Manufacturer Narrative

Inspection of the chamber, after the incident, found that the chamber safety block was out of alignment and the swing arm bottom cap pin actuator was out too far causing damage to the ball cam actuator assembly, this caused ball bearing to stay stuck in the on position and the safety pin did not engage causing chamber door to open during compression.Additional information received indicated the customer performed an adjustment to the 3-way valve, on their own, prior to the incident, which may have contributed to the reported issue.Service repair replaced the damaged parts, tested chamber to factory specifications, and confirmed that the chamber functions with no issues, as expected.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.The ifu states "always verify that the swing arm is pushed as far as it will go.A slight sound will be heard.Always push the swing arm lever firmly until it stops." therefore, no corrective or preventive 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 heard a loud noise during compression and noticed that the door latch was starting to open.Staff immediately closed the door latch and decompressed the patient back to the surface.Customer stated no injury to the patient occurred.

• Brand Name: SECHRIST MONOPLACE HYPERBARIC CHAMBER -MODEL 3200
• 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: 15568082
• MDR Text Key: 306849800
• Report Number: 2020676-2022-00025
• Device Sequence Number: 1
• Product Code: CBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K950386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3200
• Device Catalogue Number: 3200
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/1997
• 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