Description of Event or Problem · 1
PATIENT WAS FOUND DISCONNECTED FROM VENT AND EXPIRED. ALARM, WHICH HAD BEEN PREVEIOUSLY AUDIBLE, DID NOT SOUND PER NURSING STAFF. PATIENT HAD HISTORY OF DISCONNECTING CIRCUIT FROM TRACH. EVALUATION OF UNIT (5/19/93), DTERMINED DEVIATION FROM STANDARD SPECIFICATIONS. INVESTIGATION INDICATED LOW PRESSURE ALARM WAS AT A LEVEL THAT BACK PRESSURE COULD HAVE CAUSED MANOMETER TO REGISTER AS A BREATH AND NOT ALARM. ADVISED BY CALIFORNIA STATE INSPECTOR TO SUBMIT FORM PER SMDADEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: . SERVICE PROVIDED BY: MANUFACTURER. 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, MECHANICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: DESIGN - HUMAN FACTORS, INCORRECT TECHNIQUE/PROCEDURE, ALARM - LOW INSPIRATORY PRESSURE. CONCLUSION: NO FAILURE DETECTED AND PRODUCT WITHIN SPECIFICATION, THERE WAS NO DEVICE FAILURE, USER ERROR CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: USER EDUCATION PROVIDED, INSERVICED BY MANUFACTURER/DISTRIBUTOR REPRESENTATIVE, INSERVICED BY OTHER FACILITY STAFF. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.