HYPERBARIC CHAMBER

Additional Manufacturer Narrative

HOSPITAL INSTRUCTED THAT CHAMBER BE TAKEN OUT OF SERVICE. ON (B)(6) 2018, THE HOSPITAL ASSIGNED AN INDEPENDENT TECHNICIAN (B)(6) WITH (B)(4) TO INSPECT THE CHAMBER AND THE CHAMBER WAS FOUND TO MEET SPECIFICATION. ON AUGUST 27, 2018 (B)(4) WITH SECHRIST INDUSTRIES, THE CHAMBER WAS TESTED AND PERFORMED TO MANUFACTURER SPECIFICATIONS. A DHR (DEVICE HISTORY RECORD) REVIEW WAS PERFORMED. THE CHAMBER, SERIAL NUMBER (B)(4), WAS MANUFACTURED ON 07/01/2011. THERE IS NO INDICATION THAT THERE WERE ANY RELEVANT DISCREPANCIES DURING MANUFACTURING. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOUND NO NONCONFORMANCE THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED ISSUE.

Description of Event or Problem

IT WAS REPORTED THAT PATIENT EXPIRED POST TREATMENT OF HBOT (HYPERBARIC OXYGEN THERAPY). PATIENT WAS RECEIVING HIS 14TH HBOT TREATMENT OF 110 MINUTES AND WAS BEING TREATED FOR A DIABETIC FOOT ULCER. TECHNICIAN OPERATING THE CHAMBER NOTICED THE PATIENT WAS UNRESPONSIVE AND WAS REMOVED FROM THE CHAMBER, WITH NO RESPIRATION POST TREATMENT AND CPR WAS INITIATED BY STAFF. AED WAS UNTILIZED WITHOUT SHOCKS BEING GIVEN. EMS RESPONDED WITHIN 5 MINUTES AND CONDUCTED A FULL CODE FOR 50 MINUTES BEFORE PATIENT WAS PRONOUNCED DEAD.