MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC SECHRIST 3200/R MONOPLACE HYPERBARIC CHAMBER; CHAMBER, HYPERBARIC

Model Number 3200/R

Device Problem Fail-Safe Did Not Operate (4046)

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

Event Date 06/24/2021

Event Type  malfunction  

Manufacturer Narrative

Customer reported the emergency decompression button is sluggish when activated, chamber decompresses within specification, however the button has a several second delay when pressed.During routine maintenance the emergency vent, when activated, would not function properly, a delayed response before chamber started venting and no response at all when the emergency vent button was activated.Evaluation found a defective supply actuator contributed to the malfunction.A review of the device history record (dhr) for this device found no non-conformance that could have caused or contributed to the reported issue.Based on the age of the device, it is unlikely 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 #(b)(4).

Event Description

During scheduled routine maintenance, of the chamber, the emergency ventilation did not function properly.There was a delayed response before chamber started venting and no response at all when the emergency vent button was activated.There was no patient incident reported by the customer.

• Brand Name: SECHRIST 3200/R MONOPLACE HYPERBARIC CHAMBER
• Type of Device: CHAMBER, HYPERBARIC
• Manufacturer (Section D): SECHRIST INDUSTRIES, INC; 4225 e. la palma ave.; anaheim CA 92807
• MDR Report Key: 12302242
• MDR Text Key: 265854201
• Report Number: 2020676-2021-00022
• Device Sequence Number: 1
• Product Code: CBF
• Combination Product (y/n): N
• PMA/PMN Number: K950386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial
• Report Date: 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3200/R
• Device Catalogue Number: 3200-00
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2010
• 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