Description of Event or Problem · 1
DURING INDUCTION, TRANSDUCER CARTRIDGE BROKE OFF OF VENTILATOR WHEN ATTEMPTING TO CONNECT TUBING. UNABLE TO VENTILATE PATIENT - AMBU BAG WAS USED. UNABLE TO REMOVE BROKEN TRANSDUCER FROM MACHINE, HAD TO GET ANOTHER VENTILATOR FROM ANOTHER ROOM (NOTE: THE PATIENT WAS BEING BAGGED ANYWAY BECAUSE SHE WAS A DIFFERENT INTUBATION. THE POSSIBILITY CONSIST THHOUGH THAT HAD THE PATIENT BEEN INTUBATED, AND NOT BEEN ABLE TO VENTILATE, COULD HAVE DELAYED VENTILATORY SUPPORT)DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: . SERVICE PROVIDED BY: USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT. 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, A DEVICE FROM SAME LOT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: TRANSDUCER. CONCLUSION: DEVICE FAILED DURING ASSEMBLY. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: NO. CORRECTIVE ACTIONS: DEVICE REPAIRED AND PUT BACK IN SERVICE, DEVICE TEMPORARILY REMOVED FROM SERVICE, USER EDUCATION PROVIDED. THE DEVICE WAS DESTROYED/DISPOSED OF.