Description of Event or Problem · 1
A FEMALE PATIENT OF UNKNOWN AGE, IN A CODE SITUATION, WAS INTUBATED. DUE TO REPEATED CUFF LEAKS, MULTIPLE TUBE WERE USED FROM MULTIPLE MANUFACTURER, AND AT LEAST ONE TUBE WAS A SHERIDAN PRODUCT. THE HOSPITAL AT THIS TIME DOES NOT BELIEVE THE DEATH WAS A DIARECT RESULT OF INTUBATION DIFFICULTIES. SHERIDAN IS CONTINUING TO INVESTIGATE AND WILL REPORT THE FINDINGS, IN THEIR FOLLOW-UP 15 DAY WRITTEN REPORT. SUBSEQUENT INFORMATION RECEIVED INDICATES PATIENT WAS 46 YEARS OF AGE, FEMALE, TRACHEAL TUBE DEPENDENT DUE TO ACUTE RESPIRATORY DISEASE. PATIENT WAS ON VENTILATOR, AND WAS INCURRING PROBLEMS WITH LOW END TIDAL VOLUME. LEAK SUSPECTED, TUBE REPLACED, DECLINE CONTINUED. DECREASE IN TIDAL VOLUME WAS UNDETERMINED AT THE TIME. ACTUAL CAUSE OF DEATH WAS TRACHEAL LACERATIONS, WHICH WERE NOT CAUSED BY THE TRACHEAL TUBE. TUBES DID NOT CAUSE LACERATIONS AND NOT CLEAR IF TUBE MALFUNCTION ACTUALLY OCCURRED. SAMPLES RETURNED TO MFG. HOSPITAL'S OPINION - TUBE DID NOT CONTRIBUTE TO THE DEATHDEVICE 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 USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NONE OR UNKNOWN. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.