Description of Event or Problem · 1
NURSE CAME OUT OF ANOTHER ROOM. TAKING GLOVES AND MASK OFF THE NURSE NOTICED THAT THE PATIENT'S CHEST WAS NOT MOVING. SHE LOOKED AT THE MONITOR AND IT WAS READING A HEART RATE OF 229. THE NURSE PICKED UP THE INFANT, HE WAS LIMP IN HER HER ARMS. SHE PUT THE INFANT DOWN AND CALLED FOR HELP. ANOTHER NURSE HIT THE ALARM FOR ICU, COMPRESSIONS WERE STARTED. NICU NURSES RESPONDED AS WELL AS THE IN-HOUSE ANESTHESIOLOGIST. MEDICATIONS WERE ADMINISTERED AS REQUESTED BY THE PHYSICIAN. CPR WAS STOPPED TO CHECK FOR PULSE. THE MONITOR WAS READING A HEART RATE. SOMEONE CALLED OUT NO AUSCULTATED HEART BEAT. CPR WAS RESUMED. ATTENDING PHYSICIAN CALLED AN END TO THE CODE AND THE PATIENT WAS PRONOUNCED BY THE PHYSICIAN. FOLLOWING THIS THE EQUIPMENT WAS REMOVED BY BIO-MEDICAL ENGINEERING. IT WAS EVALUATED BY THE MEDICAL ENGINEERING DEPARTMENT AND THE MANUFACTURER,THE EVENT COULD NOT BE DUPLICATEDINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. 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. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: A DEVICE FROM SAME LOT WAS EVALUATED, ELECTRICAL TESTS PERFORMED. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: DEVICE DISCARDED - UNABLE TO FOLLOW-UP. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE DISCARDED, USE OF ALL SIMILAR DEVICES STOPPED TEMPORARILY. THE DEVICE WAS DESTROYED/DISPOSED OF.