Description of Event or Problem · 1
A 2 YEAR OLD WAS ADMITTED ON JANUARY 10, 1993 TO UNDERGO A TRACHEAL DIVERSION. THE MEDICAL RECORD NOTES THAT A 3.5. TRACH WAS PLACED TRACHEAL DIVERSION AND A NEW 3.5 TRACH WAS PLACED AT THAT TIME. ON JANUARY 18, 1993, THE PATIENT WAS FOUND DECANNULATED, ONE FLANGE ON THE TRACHEOSTOMY TUBE WAS SPLIT. CPR WAS INITIATED AND A COD BLUE WAS CALLED. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT WHERE HE WAS PLACED ON A VENTILATOR AND WHERE HE REMAINED UNTIL JANUARY 10, 1993.ON JANUARY 20, IT WAS NOTED THAT HE WAS BREATHING ON HIS OWN ND HE WAS TAKEN OFF THE VENTILATOR. ON THAT DAY HE WAS TRNASFERRED BACK TO A REGULAR UNIT AND HE WAS DISCHARGED FROM THE HOSPITAL ON JANUARY 27, 1993.FURTHER EXAMINATION OF THE FLANGE REVEALS THAT THE OTHER SIDE SHOWS A CRACK THAT IS BEGINNING TO SPLIT OPEN.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR 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. 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.