UNKNOWN

Description of Event or Problem

DURING THE CATH PROCEDURE IT WAS NOTED THAT HP PRESSURES AND CUFF PRESSURES WERE NOT CORRELATING. HP PRESSURES WERE 30 MM HG HIGHER THAN EXPECTED. PATIENT WAS TREATED FOR SEVERE HYPERTENSION. PATIENT RESPONDED WITH VAGAL REACTION. PRESSURE MODULE TESTED BY IN-HOUSE BIOMEDICAL ENGINEERING STAFF. 30 MM HG INACCURACY WADS RE-SIMULATED. HP SERVICE NOTIFIED. MODULE REPAIRED BY HP SERVICE. ALL OTHER EQUIPMENT USED HAD NO EFFECT ON PRESSURE INACCURACYDEVICE 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: FACTORY TRAINED/AUTHORIZED/OWNED SERVICE ORGANIZATION. 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, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: ELECTRICAL PROBLEM - OPEN CIRCUIT. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR, OTHER. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.