Description of Event or Problem · 1
PATIENT WITH ACUTE PULOMARY EDEMA, PULMONARY FIBROSIS. ON VENTILATOR W RATE SET AT 50% O2. VENT BEGAN GIVING LOW PRESSURE ALARM W PT. RECEIVING O2 AT 100%. AIR COMPRESSOR ON VENTILATOR TURNING ON AND OFF. AIR PRESSURE FROM WALL OUTLET APPEAR TO BE IN WORKING ORDER. PT. ASSISTED WITH VENTILATION UNTIL VENTILATOR CHANGED OUT. NO ADVERSE EFFECTS ON PATIENT. BIOMED INHOUSE DUPLICATED EVENT 7/5. FIELD SERVICE ENGINEER UNABLE TO DUPLICATE ON 7/8. IN HOUSE AIR PRESSURE CHECKED, OBSERVED AT 44.4 PSI. PSI INCREASED TO 52.0 PSI. OTHER DEVICES IN USE ON PT. WAS IV INFUSION PUMP, FEEDING PUM, CARDIAC MONITOR, DINAMAPP BP MONITOR, AND PULSE OXIMETER. UNABLE TO DETERMINE CAUSE. THER VENTILATORS IN USE AT TIME WITHOUT ADVERSE EVENTS.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-MAY-93. SERVICE PROVIDED BY: FACTORY TRAINED/AUTHORIZED/OWNED SERVICE ORGANIZATION. SERVICE RECORDS AVAILABLE.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. RESULTS OF EVALUATION: OTHER. CONCLUSION: DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED. 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.