STAT BLUE

Description of Event or Problem

PATIENT RECEIVED IN R ROOM - STARTED TO BAG PATIENT, NOTICED O2 SET AT 90% ON 100% O2. NOTICED HOLE IN RESERVOIR TUBING. TAPED HOLE SHUT, AND PATIENT'S O2 SAT INCREASED TO 98-99%. NO FURTHER PROBLEMS NOTED. PATIENT IS STABLE AT THIS TIMEDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE NOT SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. 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, VISUAL EXAMINATION. RESULTS OF EVALUATION: MANUFACTURING. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE, DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.