MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC. SECHRIST MNOPLACE HYPERBARIC CHAMBER - MODEL 4100H/HR; CHAMBER, HYPERBARIC, PRODUCT CODE: CBF, PRODUCT CODE: CBF

Model Number 4100H/HR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pneumothorax (2012)

Event Date 07/11/2023

Event Type  Injury  

Manufacturer Narrative

Customer is reporting that they believe the chamber is not functioning properly as there have been patient issues while in the chamber.A patient injury, pneumothorax, was reported.After the chamber was evaluated by trained sechrist technicain, it was determined that the chamber was functioning as intended and within its specifications.The customer complaint could not be confirmed.Thererfore, the patient injury was not a result of the chamber not functioning properly.There is no evidence that a manufacturing non-conformity contributed to the reported complaint, and the instructions for use (ifu) were reviewed and determined to provide adequate instructions and warnings for the safe use of the device.Therefore, no corrective or preventive actions are necessary at this time.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 asessed, documented, and acted upon as warranted.Manufacturer reference file no.:(b)(4).

Event Description

Customer contacted sechrist to inform that the chamber was not functioning as inteneded.The facility did report a patient injury, pneumothorax, while patient was inside chamber.

• Brand Name: SECHRIST MNOPLACE HYPERBARIC CHAMBER - MODEL 4100H/HR
• Type of Device: CHAMBER, HYPERBARIC, PRODUCT CODE: CBF, PRODUCT CODE: CBF
• 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 ; 7145798400
• MDR Report Key: 17393806
• MDR Text Key: 319769501
• Report Number: 2020676-2023-00013
• Device Sequence Number: 1
• Product Code: CBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 4100H/HR
• Device Catalogue Number: 4100H/HR
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• 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