HYPERBARIC CHAMBER

Description of Event or Problem

REPORTING A U.S. COMPANY - CLASSIC HYPERBARICS, INC. IN CHINO VALLEY, AZ THAT MANUFACTURES AND MARKETS NON-CODE COMPLIANT MEDICAL DEVICES (PRODUCT CODE CBF) THAT DO NOT POSSESS FDA 510K CLEARANCE TO DO SO. THEY ARE ALSO NOT LISTED WITH THE FDA AS A MEDICAL DEVICE MANUFACTURER. ONE OF THEIR NON-COMPLIANT MEDICAL DEVICES (PRODUCT CODE CBF) CATASTROPHICALLY FAILED AT A WELLNESS CENTER IN (B)(6), INJURING TWO OCCUPANTS ON (B)(6), 2023. THE INCIDENT WAS REPORTED TO ME BY FIRE CHIEF (B)(6). INDIVIDUALS NEARBY REPORTED THAT THEY HEARD AN EXPLOSION. THE OFFICE SPACE WHERE THE INCIDENT OCCURRED IS IN A STRIP MALL STYLE BUILDING WITH SEPARATE BUSINESS SHARING THE NORTH WALL AND SOUTH WALL. THE TENANTS ON BOTH SIDES WERE EXTREMELY STARTLED BY THE EXPLOSION, BELIEVING A VEHICLE MAY HAVE STRUCK THE BUILDING. THERE WERE TWO INDIVIDUALS IN THE CHAMBER WHEN THE INCIDENT OCCURRED. ONE OF THE INDIVIDUALS WAS UNCONSCIOUS WHEN MEDICAL PERSONNEL ARRIVED ON SCENE. HE WAS TRANSPORTED TO THE HOSPITAL. (B)(6) (BUSINESS OWNER) STATED THAT 1 MINUTE PRIOR TO THE FAILURE OF THE GLASS HE WAS STANDING DIRECTLY IN FRONT OF THE SITE GLASS WHICH HAD FAILED. HE STATED HE WAS GOING THROUGH HIS ROUTINE AND CHECKING THE STATUS OF THE TWO OCCUPANTS WITHIN. AFTER COMPLETING THE SETUP OF THE HYPERBARIC CHAMBER (B)(6) WENT TO THE BACK OF HIS OFFICE TO CHECK ON THE COMPRESSOR. HE THEN RETURNED TO THE FRONT OF THE OFFICE BEHIND THE MAIN DESK. THE EXPLOSION OCCURRED AND HE REPORTED BEING THROWN TO THE FLOOR. HE SHORTLY REALIZED WHAT HAD HAPPENED. ONCE (B)(6) AND THE NEIGHORBORING OCCUPANTS HAD REALIZED WHAT HAD HAPPENED, THEY WORKED TOGETHER TO REMOVE THE TWO INDIVIDUALS FROM WITHIN THE CHAMBER. 911 WAS CALLED AND FIRST RESPONDERS ARRIVED AND PATIENT CARE WAS RENDERED PRIOR TO TRANSPORTATION TO A MEDICAL FACILITY. THE DETAILS OF THIS CATASTROPHIC FAILURE ARE INCLUDED IN THE ATTACHED PHOTOS.