Description of Event or Problem · 1
AT APPROX. 7:30 A.M., PATIENT WAS FOUND TO BE DISCONNECTED FROM THE LP-6 VENTILATOR TUBING AT THE TRACH TUBE. THE LOW-PRESSURE (APNEA) ALARM WAS NOT ALARMING DUE TO TO EXCESSIVE MOISTURE BUILDUP IN THE ARC-6000 HEAT MOISTURE EXCHANGER (HME). THE HME HAD BEEN IN USE FOR APPROX. 44 HOURS AND HAD BEEN CHECKED BY RESPIRATORY TECHNICIAN (MIKE BARNES) AT 6:09 A.M. AT THAT TIME THE ALARMS WERE CHECKED AND WERE OPERATING PROPERLY. CHECKOUT OF THE VENTILATOR SHOWED THE LOW PRESSURE ALARM SET AT 18 CM OF H20 PRESSURE. WITH THE VENTILATOR TUBING DISCONNECTED FROM THE PATIENT THE PRESSURE MANOMETER SHOWED 18-20 CM'S OF BACK PRESSURE (JUST OVER THE LOW PRESSURE SETTING) THUS KEEPING THE VENTILATOR FOR ALERTING STAFF TO THE EMERGENCYDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. 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, VISUAL EXAMINATION. RESULTS OF EVALUATION: MECHANICAL PROBLEM, FAILURE TO SERVICE/MAINTAIN ACCORDING TO MANUFACTURER RECOMM, ALARM - LOW INSPIRATORY PRESSURE. CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT, DEVICE FAILURE DIRECTLY CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE, USER EDUCATION PROVIDED, INSERVICED BY OTHER FACILITY STAFF. THE DEVICE WAS DESTROYED/DISPOSED OF.