Description of Event or Problem · 1
RESPIRATORY TECHNICIAN MIS-APPLIED A SIMPLE AEROSOL TREATMENT DEVICE IN A MANNER WHICH PREVENTED AN UNCONSCIOUS PATIENT'S ATTEMPTS TO EXHALE. THIS CONTRIBUTED TO THE RESPIRATORY EMERGENCY; THE PATIENT SUFFERED A FULL ARREST AND SUBSEQUENTLY DIED. THE END OF THE TUBING WAS OCCLUDED WITH TAPE WHICH ALTERED THE NORMAL OPERATIONS OF THE EQUIPMENTDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL 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 NOT USED AS LABELED/INDENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION, OTHER. RESULTS OF EVALUATION: MODIFICATION OF DEVICE - BY USER, NONE OR UNKNOWN, INCORRECT TECHNIQUE/PROCEDURE, MISAPPLICATION OF DEVICE. CONCLUSION: THERE WAS NO DEVICE FAILURE, USER ERROR CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: USER EDUCATION PROVIDED, OTHER. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.