MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC SECHRIST 2800/R MONOPLACE HYPERBARIC CHAMBER; CHAMBER, HYPERBARIC

Model Number 2800/R

Device Problem Emergency Power Failure (1205)

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

Event Date 11/20/2021

Event Type  malfunction  

Manufacturer Narrative

This report is based solely on the customer reported issue.Additional information has been requested, but no new information has been received.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

Customer reported the pressure is not released from the chamber only after closing the inlet source, and when closing the source, pressure drops quickly which is not recommended, plus the emergency pressure release is not working to release the pressure from the chamber.No patient incident was reported.

• Brand Name: SECHRIST 2800/R MONOPLACE HYPERBARIC 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: 12987312
• MDR Text Key: 287532624
• Report Number: 2020676-2021-00035
• Device Sequence Number: 1
• Product Code: CBF
• Combination Product (y/n): N
• Reporter Country Code: LE
• PMA/PMN Number: K950386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/13/2021

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: 2800/R
• Device Catalogue Number: 2800/R
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/22/2021
• Initial Date FDA Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2009
• 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