Description of Event or Problem · 1
FOLLOWING THE CHANGE OF A STAR FILTER THE VENTILATOR WAS NOTED TO HAVE UNUSUALLY LOUD SOUND AT 0754. AT 0755 THE PATIENT WAS REMOVED FROM THE VENTILATOR AND MANUALLY VENTILATED AT 100% WITH +8 CM H2 PEEP DUE TO FALLING HR. SPO2 REMAINED AT 99% ON VENTILATOR. 0807 HR 110-112 RETURNED TO VENTILATOR AFTER INTERNAL CONNECTION REPAIRED AT BEDSIDE. 0812 HR LOWERED AFTER SP02 DROPPED TO 94%. VENTILATOR ALARMED - LOW - MIN VOL. AT 7LPM (PATIENT NORMAL 15-16 LPM) 0812 PATIENT MANUALLY VENTILATED AT 100% 02. 0815 VENTILATOR SWITCHED OUT WITH NEW VENTILATOR.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-NOV-91. SERVICE PROVIDED BY: USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT. 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, ELECTRICAL TESTS PERFORMED, MECHANICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: COMPONENT FAILURE, INVALID DATA. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT, DEVICE WAS OUT OF CALIBRATION. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE REPAIRED AND PUT BACK IN SERVICE, INSERVICED BY BIOMEDICAL ENGINEERING DEPT. STAFF. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.