Description of Event or Problem · 1
THANK YOU ONCE AGAIN FOR LOOKING AT THIS VOLUNTARY SUBMISSION WITH PT CHART NUMBER AS THE IDENTIFIER AT (B)(6) IN (B)(6) IN YET ONE MORE ATTEMPT TO CONTINUE SUPPORTING DATA FOR SCENARIO #2. MR (B)(6), DIRECTOR OF NURSING WOULD CONTINUE TO BE HAPPY TO ASSIST THE FDA WITH THE FETAL MONITORING STRIP AND NOTES FROM THE SYSTEM TO CONTINUE TO POTENTIALLY IDENTIFY LIFE THREATENING FETAL MONITOR FLAWS ON THE AVALON FM FETAL MONITORING SYSTEM BY (B)(4), HEALTHCARE RECALL # Z-0552-2010 MR (B)(6) CAN BE REACHED AT (B)(6). IN THIS EXAMPLE, IT IS RELATIVELY UNEVENTFUL LABOR WITH A QUESTION OF VARIABLE DECELS STARTING TO OCCUR APPROX AT 1138. OTHERWISE IT APPEARS TO BE AN AVERAGE FETAL MONITOR STRIP FROM 0032-1138. AT 1150, A FETAL SCALP ELECTRODE -FSE- IS PLACED AS OUTLINED IN THE (B)(4) MANUAL AND THE CLASS 2 RECALL AT THE TOP OF PAGE 2. TWO SEPARATE TRACINGS OCCUR, MEANING THERE IS A CLEAR MATERNAL AND FETAL HEART RATE TRACINGS. AT 1206, "COINCIDENCE STATUS ON" ALARMS. BEFORE THIS POINT FROM 1150-1206, THE FETAL SCALP ELECTRODE APPEARED TO BE FUNCTIONING PROPERLY BUT SUDDENLY AT 1205, IT GIVES THE APPEARANCE OF SPIRALING AROUND THE MATERNAL HEART RATE SIMULTANEOUSLY AND W/O WELL KNOWN ARTIFACTS THAT CAN OCCUR WITH A FETAL SCALP ELECTRODE. SO THEREFORE, IF A FETAL SCALP ELECTRODE IS USED TO VERIFY FETAL HEART TONES AS OUTLINED IN THE CLASS 2 RECALL ON PAGES ONE AND TWO, THEN THE QUESTION IS THAN AGAIN RAISED. WHAT IS TO BE USED WHEN THE "VERIFY TO VERIFY" NEEDS VERIFICATION TO VERIFY WHAT'S THERE? ANOTHER WORDS ... "IF HEALTHCARE PROFESSIONALS WHEN QUESTIONING THE FETAL HEART TONES ON THE ULTRASOUND TRANSDUCER ARE VERIFIED WITH A FETAL SCALP ELECTRODE AND THEN THE SCALP ELECTRODE DECIDES TO CONTINUE TRACING W/O THE USUAL ARTIFACTS AND UNINTERRUPTED AROUND THE MATERNAL HEART RATE HOW IS THE HEALTHCARE PROFESSIONAL TO KNOW WHEN TO VERIFY WHAT'S ALREADY BEING VERIFIED AS OUTLINED IN THE CLASS 2 RECALL?" THANK YOU FOR YOUR CAREFUL CONSIDERATION IN THIS SERIOUS MATTER OF POTENTIALLY LIFE THREATENING FLAWED FETAL MONITORS THAT ARE IN USE NATIONALLY AS WELL AS INTERNATIONALLY. IN NURSING SCHOOL WE ARE TAUGHT TO BE PROACTIVE FOR OUR PTS. IN THE FACILITY THAT I WORK AT, I MADE A DIFFERENCE BY CONVINCING ADMINISTRATION TO HAVE THIS FETAL MONITOR REMOVED FROM MY FACILITY IN (B)(6) 2010. MY CONSCIOUS WON'T LET ME STOP THERE. MY SUBMISSIONS TO FDA MEDWATCH ARE FOLLOW UPS OF THE COMPLAINT SUBMITTED BY (B)(6) ON (B)(6) 2010 AT WHICH TIME ALL THAT OCCURRED WAS A REINSTATEMENT OF THE PREVIOUSLY ISSUED CLASS 2 RECALL. I FIND IT INTERESTING THOUGH THAT AFTER I SPOKE WITH (B)(6), LEAD APPLICATION SPECIALIST FROM (B)(6) HEALTHCARE ON (B)(6) 2010 WITH 11 VERY INTRICATE AND DIRECT QUESTIONS ABOUT THEIR FETAL MONITORING SYSTEM. (B)(6) HEALTHCARE ISSUED A FULL REFUND OF OVER 2 MILLION DOLLARS TO MY FACILITY WITH NO QUESTIONS ASKED. BUT AS A SINGLE MOTHER OF 3 AND 20 YRS OF LABOR AND DELIVERY EXPERIENCE, I CAN'T HELP BUT ASK MYSELF AS WELL AS EVERYONE AROUND ME AND THE FDA. WHAT IF IT WAS MY BABY? YOUR BABY? OUR BABY? WHAT WOULD YOU DO? I WISH THAT I HAD BEEN INCLUDED IN THAT REPORT, I WORKED SO HARD TO GET THE DATA FROM (B)(6) 2010. MAYBE I COULD HAVE ACTUALLY MADE A DIFFERENCE. WITH SINCERE APPRECIATION AND THANK YOU FOR LISTENING AND INVESTIGATING WHAT I HAVE TRIED TO DESCRIBED AS POTENTIALLY LIFE THREATENING FLAWS ON THE AVALON FM FETAL MONITORING SYSTEM. (B)(6), RN.