ADULT VENTILATOR

Description of Event or Problem

DEVICE IN USE & OPERATING CORRECTLY. STAFF REPORTED EXHALED TIDAL VOLUMES IN EXCESS OF SET VOLUMES. VENT REMOVED FROM SERVICE. VENT TESTED 7/11/94, TIDAL VOLUMES 50% ABOVE SWITCH SETTING. PEAK FLOWS MEASURED AT 30% - 75% ABOVE SWITCH SETTING. REPLACED DEFECTIVE PURGE VALVE. PERFORMED CALIBRATION TESTS TO VERIFY CORRECT OPERATION. RAN VENT 24 HRS. TO BURN-IN. FULL OPERATIONAL VERIFICATION. RETURNED TO SERVICE 7/14/94.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-MAY-94. SERVICE PROVIDED BY: INDEPENDENT FACTORY TRAINED/AUTHORIZED SERVICE ORGANIZATION. SERVICE RECORDS AVAILABLE.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: TELEMETRY FAILURE, OTHER. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE REPAIRED AND PUT BACK IN SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.