MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC SECHRIST 3200P/PR MONOPLACE HYPERBARIC OXYGEN CHAMBER; CHAMBER, HYPERBARIC

Model Number 3200R

Device Problem Fail-Safe Problem (2936)

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

Event Date 03/03/2021

Event Type  malfunction  

Manufacturer Narrative

Sechrist field technician found the chamber emergency decompression was out of specification, at 125 seconds.Field technician checked the exhaust screen and determined the cause to be a clogged lint on the inside of the exhaust screen.Replaced the exhaust screen and retested the chamber emergency decompression.The chamber decompressed within specification at 80 seconds.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.Chambers are multi-use, serviceable items.As such, it is anticipated that the units may occasionally require repair, and as part of standard care the chambers should be inspected prior to use.If damage or functional issues are noted during these routine chamber inspections, the unit should not be put into use with a patient and should be reported to sechrist for servicing.Manufacturer reference file #(b)(4).

Event Description

Customer reported the chamber emergency ventilation is taking longer than 2 minutes to decompress from the 3ata and makes a weird rubbery noise.The issue was discovered during pre-clinical check and no patient incident was reported.

• Brand Name: SECHRIST 3200P/PR MONOPLACE HYPERBARIC OXYGEN CHAMBER
• Type of Device: CHAMBER, HYPERBARIC
• Manufacturer (Section D): SECHRIST INDUSTRIES, INC; 4225 e. la palma ave.; anaheim CA 92807
• MDR Report Key: 11606040
• MDR Text Key: 245154972
• Report Number: 2020676-2021-00008
• 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: 04/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3200R
• Device Catalogue Number: 3200R
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2004
• 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