Description of Event or Problem · 1
FIVE YEAR OLD MALE DEPENDENT ON LP10 VENTILATOR FOUND IN CARDIAC ARREST AT 4:35 P.M. ON FEBRUARY 13, 1993, BY R.N. AT TIME OF RN ENTERING CHILD'S ROOM NO VENTILATOR LIGHTS OR ALARMS WERE EVIDENT. CHILD REPOSITIONED ONTO BACK AND SECOND RN ENTERING NOTED VENTILATOR LIGHT GO ON FOLLOWED BY AUDIBLE ALARM. SECOND RN NOTED VENTILATOR CIRCUIT BECAME DISCONNECTED WHEN CHILD WAS REPOSITIONED ON HIS BACK BY ARN; HOWEVER, THIS IS NOT COMPLETELY TRACABLE - THUS REPORT IS FILED. CHILD HAD TETROLOGY OF FALLOT S/P MODIFIED LEF BLALOCK-TAUSSIA CARDIAC SHUNT DONE IN 1988. HE HAD HISTORY OF CARDIAC "TET" SPELLS. AUTOPSY WAS PERFORMED, BUIT NO RESULTS ARE AVAILABLE YET. OTHER DEVICES USED AT THE TIME WERE THE FOLLOWING: 1. NONIN MEDICAL - PULSE OXIMETER2. FISHER PAYKEL - HEATER3. AIRSEP - OXYGEN CONCENTRATOR (FOR LIFEDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-JAN-93. SERVICE PROVIDED BY: INDEPENDENT SERVICE ORGANIZATION. SERVICE RECORDS AVAILABLE.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, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: TELEMETRY FAILURE, NONE OR UNKNOWN, NONE OR UNKNOWN, NONE OR UNKNOWN. CONCLUSION: DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.