MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC SECHRIST 3600E/ER MONOPLACE HYPERBARIC CHAMBER; CHAMBER, HYPERBARIC PRODUCT CODE: CBF

Model Number 3600E/ER

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

Patient Problems Cardiopulmonary Arrest (1765); Death (1802)

Event Date 09/21/2020

Event Type  Death  

Manufacturer Narrative

This report is based solely on the customer report of a death.No device malfunction was reported.The device was not returned to sechrist.Sechrist certified technician visited the facility and evaluated the device.Technician completed chamber performance evaluation on (b)(6) 2020, after patient incident.Chamber performed per manufacturer's annual preventive maintenance specifications and no errors were noted.The instructions for use state "hyperbaric chambers are designed to administer oxygen at 100% concentration up to 3.0 atmospheres absolute (ata) of pressure." the ifu also states "contraindications must be carefully weighed by the physician with each patient's unique preexisting conditions or concurrent therapies." 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.(b)(4).

Event Description

Sechrist was notified, by a third party, about a social media post, of a child's death at a hyperbaric therapy clinic, which prompted sechrist to contact the facility.Sechrist was not initially notified by the clinic when the incident took place.Sechrist contacted the customer who reported that their facility treated an (b)(6)-month old child who suffered a near drowning incident, which occurred in (b)(6) 2020, and left the child in a vegetative and unresponsive state.The child, accompanied by his father inside the chamber completed a 60 minute hyperbaric treatment.This was the child's first treatment.After the treatment, the child was administered cpr and taken to the emergency room.The hbo facility was informed the child passed of cardiorespiratory arrest.

• Brand Name: SECHRIST 3600E/ER MONOPLACE HYPERBARIC CHAMBER
• Type of Device: CHAMBER, HYPERBARIC 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 ; 7145798309
• MDR Report Key: 10668229
• MDR Text Key: 210982501
• Report Number: 2020676-2020-00016
• Device Sequence Number: 1
• Product Code: CBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3600E/ER
• Device Catalogue Number: 3600E/ER
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2008
• 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
• Patient Outcome(s): Death
• Patient Age: 18 MO