3600E HBO CHAMBER, 36IN, ELECTRONIC CONTROL

Description of Event or Problem

PATIENT'S FIRST TREATMENT AND WAS TAUGHT HOW TO CLEAR EARS. TWELVE MINUTES INTO TREATMENT, GOING DOWN TO PRESSURE AND COMPRESSING AT 1.0PSI/MINUTE HEADING TOWARD 2ATA. WHEN THE CHAMBER GOT TO 1.52ATA, IT SUDDENLY WENT BACK UP TO 1.20ATA. THEN IT WENT FROM 1.20ATA BACK TO 1.52ATA IN 5 SECONDS. THIS APPEARED TO CAUSE EAR PAIN TO THE PT AS THE PT GRABBED HER HEAD. ATTENDANT SET THE PRESSURE DOW TO 1.10ATA TO STOP THE CHAMBER PRESSURE FROM ELEVATING. THE NEW SET PRESSURE WAS AT 1.10ATA ON THE DIAL AND THE PRESSURE CONTINUED GOING UP. IT FINALLY STOPPED AT 1.57ATA AND THEN STARTED COMING DOWN AT A NORMAL RATE, SLOWLY, AT 1PSI/MINUTE. THE DOCTOR CHECKED THE PT AFTER THE PT WAS REMOVED FROM THE CHAMBER AND SAID PT HAD A TEEDS READING OF T3 ON THE RIGHT EAR.

Additional Manufacturer Narrative

DEVICE FAILURE RELATED TO LOSS OF PRESSURE AT USER FACILITY. DEVICE REQUIRES 45 TO 70 PSI PRESSURE. PRESSURE READING AT THE MAIN GAUGE READ 40 PSI.