ANESTHESIA BAGS

Description of Event or Problem

ON 1/11/91, TWO ANESTHESIA BAGS FAILED DURING USE ON TWO INFANTS IN THE NEONATAL INTENSIVE CARE UNIT. THE LEAK VALVE ON BOTH BAGS WENT PAST THEIR STOP, CAUSING A LEAK IN THE SYSTEM WITH FLOW RATES AS HIGH AS 15 LITERS PER MINUTE, THE FREQUENCY RESPONSE OF THE BAGS WERE REDUCED TO ABOUT TWENTY BREATHS PER MINUTE. THERE WERE OTHER AVAILABLE ANESTHESIA BAGS THAT WERE USED. AS A RESULT, THE BABBIES DID NOT EXPERIENCE ANY APPARENT COMPLICATIONSINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING 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. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.