MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC. HYPERBARIC CHAMBER

Model Number	2500B/BR
Health Effect - Clinical Code	Death (1802)
Date of Event	08/22/2015
Type of Reportable Event	Death
Additional Manufacturer Narrative
Sechrist made several attempts to try and obtain the chamber for evaluation.Several phone calls were made to dr.(b)(6) at (b)(6) and messages were never returned.Based on device history review, this chamber was in use beyond the current pvho regulated cylinder life of 20 years and was manufactured in 1989.This hyperbaric chamber was originally sold to (b)(6) hospital and sechrist conducted annual preventative maintenance through 1998.At no time was sechrist made aware of relocation of this chamber to any other facility.(b)(6) fire investigation stated that dr.(b)(6) purchased the chamber on (b)(6).Based on (b)(6) fire investigations sechrist industries also learned that dr.(b)(6) placed a battery operated fan in the chamber while in use.Introduction of any type of heat source into a hyperbaric chamber is strictly against manufacturer recommendations as well as nfpa99 health care facilities code, chapter 14 hyperbaric facilities.: device not provided for evaluation.
Event or Problem Description
Sechrist industries received an email from (b)(6) with (b)(6) news stating that they would be airing a story about a fire that took place inside a hyperbaric chamber at (b)(6).Reportedly, (b)(6) brought her dog to the veterinarian clinic where dr.(b)(6) gave the dog oxygen therapy by putting the dog inside a hyperbaric chamber.During therapy the chamber caught on fire, killing the dog.

• Brand Name: HYPERBARIC CHAMBER
• Common Device Name: HYPERBARIC CHAMBER
• Manufacturer (Section D): SECHRIST INDUSTRIES, INC.; 4225 e. la palma avenue; anaheim CA 92807
• MDR Report Key: 5855494
• Report Number: 2020676-2016-00005
• Device Sequence Number: 171042
• Product Code: CBF
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K140559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: 2500B/BR
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2016
• Initial Report FDA Received Date: 08/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death