Description of Event or Problem · 1
FETAL MONITORS/ CTG OF MANUFACTURER: BISTOS CO. LTD., (B)(4) MODEL BT-350 WITH FDA NO. K103545 WERE INSTALLED WITH CENTRAL MONITORING SYSTEM AT (B)(6) HOSPITAL (B)(6) ON (B)(6) 2017. USER DEPARTMENT REPORTED OF BURNS AT MOTHER SITE WHERE TOCO SENSORS WERE PLACED ON (B)(6) 2017, THE ADVERSE EVENT WAS REPORTED TO MANUFACTURER FIRM AND REPLACEMENT OF TOCO SENSORS WERE MADE FOR FURTHER PREVENTION OF EVENT. ON (B)(6) 2018 EVENT OF PATIENT BURN RECURRED AT THE MOTHER SITE WHERE US AND TOCO SENSORS WERE PLACED, ALSO THE USER DEPARTMENT INFORMED ABOUT THE ARBITRARY READINGS OF FHR EVEN WITHOUT PLACING THE SENSOR ON ACTUAL FETUS LOCATION. THE EVENT WAS REPORTED TO MANUFACTURER AND NO SIGNIFICANT RESOLUTION HAD BEEN FOUND TILL DATE. FURTHER USE OF MACHINES HAD BEEN TERMINATED DUE TO LIFE THREATENING ISSUES TO FETUS BECAUSE OF THE FALSE READINGS MACHINES ARE PRODUCING THAT USER WOULD CONSIDER AS SAFE READINGS OBSERVING ON CENTRAL MONITOR EVEN IF THERE HAD BEEN DISTRESS TO THE FETUS.