Description of Event or Problem · 1
IT WAS REPORTED TO TYCO HEALTHCARE/KENDALL ON 05/04/2007 THAT THE CABLE WAS NOT WORKING. THE CABLE WAS USED TO MONITOR THE FETAL HEART RATE. IN THIS INCIDENT, THE BABY DID EXPIRE. THE FETAL SCALP ELECTRODE INVOLVED IN THE INCIDENT HAS BEEN DISCARDED. DURING THE INCIDENT, THEY BEGAN EXTERNALLY MONITORING. THEY WERE LOSING THE HEART RATE, AND THEREFORE, DECIDED TO MONITOR INTERNALLY. THEY ATTACHED THE FSE AND CABLE, AND COULD NOT GET A SIGNAL. THEY THEN SWITCHED THE CABLE OUT, AND WERE THEN ABLE TO GET A SIGNAL. REPORTER OF INCIDENT WAS UNSURE IF THEY CONTINUED TO MONITOR EXTERNALLY, WHILE THEY SWITCHED TO INTERNAL MONITORING. THE CABLE WAS USED FOR APPROXIMATELY 6 MONTHS, UNSURE HOW LONG/FREQUENTLY CABLE USED. CABLES ARE STORED IN A DRAWER WITH THE MONITOR. CABLE DID NOT WORK WHEN TESTED WITH GE BIOTEK LIONHEART MPS-I MACHINE. A BRAND NEW COREMETRIX GE 250 MACHINE WAS USED IN THE INCIDENT. ALSO USING Y CONNECTOR E9005GH. PREGNANCY WAS NORMAL, NO COMPLICATIONS. ADVANCED MATERNAL AGE, POLYHYDRAMNIOS. THE MOTHER HAD BEEN CHECKED BY OB/GYN AND EVERYTHING APPEARED NORMAL; SHE WAS LABORING NORMALLY. THE DELIVERY OF THE BABY WAS NORMAL. THE BABY DID NOT BREATHE EXTERNALLY FROM THE MOTHER AND DIED IN UTERO. REPORTER OF THE INCIDENT STATED THAT THE CABLE DID NOT CONTRIBUTE TO THE DEMISE OF THE BABY, HOWEVER, WAS A PROBLEM THAT OCCURRED DURING THE REPORTED INCIDENT. THE CABLE WILL NOT BE RETURNED AS THE HOSPITAL IS KEEPING THE CABLE IN THEIR POSSESSION. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, RESULTS WILL BE FORWARDED.