HYPERBARIC CHAMBER

Description of Event or Problem

PT WAS PLACED IN HYPERBARIC CHAMBER #3 AFTER A SAFETY CHECK, THE CHAMBER WAS CLOSED AND THE SYSTEM WAS TURNED ON. A SUDDEN DROP IN THE MAIN PRESS AND A SUDDEN INCREASE OF PRESSURE INSIDE THE CHAMBER OCCURRED UP TO 3 DSIG IN 10-15 SECONDS. A LOUD "BURST" WAS NOTED. SYSTEM TURNED OFF AND PT REMOVED. PT COMPLAINED OF BUZZING IN EARS AND HEADACHE.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: . SERVICE PROVIDED BY: INVALID DATA. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, ELECTRICAL TESTS PERFORMED, MECHANICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED, NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: USER EDUCATION PROVIDED. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.