HYPERBARIC CHAMBER

Description of Event or Problem

WHILE PATIENT IN HYPERBARIC CHAMBER HE NOTICED A "POPPING" SOUND AT THE SAME TIME THAT THE HYPERBARIC R.N. NOTICED LOSS OF PRESSURES TO THE SET PRESSURE DIAL AND THE CHAMBER PRESSURE DIAL RESULTING IN A LOSS OF OXYGEN PRESSURE. AFTER A RAPID CHECK TO ASSESS FOR CORRECTION THE CHAMBER WAS DECOMPRESSED FROM 2ATA TO SURFACE PRESSURE. THE APPROXIMATE TIME TO SURFACE PRESSURE WAS REESTIMATED AT ONE MINUTE 20 SECONDS. THE PATIENT COMPLAINED OF MILD BILATERAL "EAR PAIN" AND WAS EVALUATED BY THE HBO M.D. MFG. WAS CALLED AND NOTIFIED OF INCIDENT. A SERVICE REPRESENTATIVE ARRIVED ON 3/4/92 AND AFTER CHECKING THE SAFETY SWITCH AND TUBING, REPLACED A 3-WAY SAFETY VALVEDEVICE 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: 01-DEC-91. SERVICE PROVIDED BY: MANUFACTURER. 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, MECHANICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: MECHANICAL PROBLEM, UNANTICIPATED SHORT TERM COMPLICATION OF PROCEDURE, VALVE. CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT, DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: INSERVICED BY MANUFACTURER/DISTRIBUTOR REPRESENTATIVE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.