Description of Event or Problem · 1
KEY POINTS OF DISAGREEMENT WITH CLASS 2 RECALL FROM THE AVALON FETAL MONITORS BY PHILIPS HEALTHCARE, INC. FROM THE POINT OF A 20 YEAR LABOR AND DELIVERY NURSE WORKING CLOSELY WITH THE AVALON FM 50 FETAL MONITOR SERIES IN PARTICULAR ((B)(6) 2009-(B)(6) 2010). DATE OF ORIGINAL CLASS 2 RECALL IS 11/20/2009. DATE OF REINSTATEMENT OF CLASS 2 RECALL 1/12/2010. DATE OF REQUEST FOR FDA CONSIDERATION FOR TOTAL RECALL IS 12/20/2010. IN NURSING SCHOOL WE ARE TAUGHT TO BE PROACTIVE FOR OUR PATIENTS. 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 CONSCIENCE WON'T LET ME STOP THERE. MY SUBMISSION TO THE FDA IS A FOLLOW UP OF THE COMPLAINT SUBMITTED BY (B)(6) MED CTR IN (B)(6) DATED 1(B)(6) 2010 AT WHICH TIME ALL THAT OCCURRED WAS A REINSTATEMENT OF THE PREVIOUSLY ISSUED CLASS 2 RECALL ON 11/20/2009. AS A SINGLE MOTHER OF 3 WITH 20 YEARS OF LABOR AND DELIVERY EXPERIENCE, I IMPLORE YOU TO TAKE ANOTHER LOOK AT THIS PIECE OF VITAL EQUIPMENT USED IN NUMEROUS DELIVERIES ACROSS THE UNITED STATES. THE CORE OF MY PURPOSE FOR THIS LETTER IS SIMPLE. WHAT IF IT WAS MY BABY?...IF IT WERE MY BABY, THEN I WOULD WANT A NURSE LIKE ME TO COME OUT OF THE WOOD WORK AND TRY WITH EVERYTHING SHE HAD TO PROTECT HER PT, THE UNBORN. THE FACILITY I WORK AT HAD A TOTAL OF (B)(6) OF THE PHILIPS AVALON FETAL FM 50, CATALOG NUMBER: M2705A AND RECALL NUMBER Z-0552-2010 TO INCLUDE ALL SERIAL NUMBERS. SUSPECTED FETAL MONITOR FLAW #1: ON PAGE 1 OF THE 17 PAGE ADDENDUM CLASS 2 RECALL FROM PHILIPS HEALTHCARE, INC. ORIGINALLY ON 11/20/2009, PHILIPS REFERS TO SPECIFIC SITUATIONS REQUIRING SUCH CONFIRMATION TO INCLUDE THE FOLLOWING: WHEN THE MOTHER'S HEART RATE BASELINE IS WITHIN 15 BEATS PER MINUTE OF THE BABY'S HEART RATE. HOWEVER, FOR THOSE OF US WHO HAVE USED THIS MONITORING SYSTEM IN CLINICAL PRACTICE IT IS NOT UNCOMMON TO SEE THE FETAL HEART RATE BEAT DIFFERENCE TO BE AS MUCH AS 20-25 BEAT DIFFERENCE WHICH IS OUT OF THE RANGE SPECIFIED IN THE CLASS 2 RECALL ORIGINALLY ISSUED BY THE FDA 11/20/2009. SUSPECTED FETAL MONITOR FLAW #2: ON 1/5/2010, THERE WAS A PHONE CONVERSATION AT MY FACILITY BETWEEN MYSELF, TWO COLLEAGUES AND A LEAD APPLICATION SPECIALIST FROM PHILIPS HEALTHCARE, INC. THIS PERSON SAID THAT THERE COULD BE UP TO A 10 SECOND DELAY FROM THE MOTHER'S HEART RATE TRACING COMPARED TO THE COINCIDING BABY'S HEART RATE TRACING. THIS IS NOT MENTIONED AT ALL IN THE CLASS 2 RECALL DATED 11/20/2009. THE ORIGINAL MANUAL TO THE AVALON FM 50 FETAL MONITOR MENTIONS THIS DELAY COULD BE UP TO 6 SECONDS. IN ACTUAL CLINICAL PRACTICE THIS UP TO "10 SECOND DELAY" IN COINCIDING HEART RATE TRACINGS BETWEEN THE MOTHER AND THE FETUS ACTUALLY CAN BE DELAYED UP TO 20-30 SECONDS. WHICH THEN BRINGS THE QUESTION THAT IF THE VISUAL PAPER TRACING OF THE FETAL HEART RATE TRACING COMPARED TO THE MATERNAL HEART RATE TRACING HAS 2 SUBSTANTIALLY DIFFERENT TRACINGS AND DELAYED 10+ SECONDS. AS A 20 YEAR LABOR AND DELIVERY NURSE IT SEEMS WE HAVE TAKEN A STEP BACK IN TECHNOLOGY. THE 1980 FETAL MONITORING TECHNOLOGY THAT WAS REPLACED BY THIS NEW SYSTEM WOULD HAVE THE 2 HEART RATES COINCIDED ON THE FETAL MONITOR STRIP BETWEEN THE MOTHER AND BABY AS WELL AS AUDIBLY ALARM AT THE MAIN NURSES STATION DESK. HOW CAN THIS AUDIBLE ALARM TAKE PLACE IF ALSO FROM THE PHONE CONVERSATION ON 1/5/2010, IF 80% OF ANY ONE MINUTE TIME FRAME IN ACTUAL MONITORING HAS TO HAVE BOTH THE MATERNAL AND THE FETAL HEART RATE COINCIDING TO AUDIBLY ALARM AT THE CENTRAL MONITORING STATION. IT WOULD BE IMPOSSIBLE AND AT THE LEAST RATE WITH SUCH A SUSPECTED FLAWED SEPARATION OF COINCIDING MOTHER AND FETAL HEART RATES OF 10-25 BEATS WITH A 10-30 SECOND DELAY TO EVER POSSIBLY ALARM. SUSPECTED FETAL MONITOR FLAW #3: THE NEW TECHNOLOGY OF THIS FETAL MONITOR HAS WHAT IS CALLED A "CCV FEATURE" WHICH IS ALSO KNOWN AS CROSS-CHANNEL VERIFICATION. THIS IS DISCUSSED IN GREAT DETAIL IN THE CLASS 2 RECALL DATED 11/20/2009. PLEASE MAKE NOTE AT THE BOTTOM OF PAGE 1 OF THE CLASS 2 RECALL TO THE TOP OF PAGE 2. PHILIPS HEALTHCARE, INC. WRITES THAT IF THERE IS ANY CONCERN THAT THE FHR (FETAL HEART RATE) TRACING IS NOT ACCURATE, TAKE ADD'L STEPS TO CONFIRM THE FETAL HEART RATE BY USING: AN OBSTETRIC STETHOSCOPE, AN ULTRASOUND IMAGING, A FETAL SCALP ELECTRODE. NOWHERE IN THE CLASS 2 RECALL DATED 11/20/2009 OR THE PHILIPS HEALTHCARE, INC MANUAL DOES IT TALK ABOUT THE CCV CONTINUING TO BE EMPLOYED WITH A FETAL SCALP ELECTRODE THAT IS TO BE USED TO VERIFY THE FETAL HEART TONES. HOW DOES THE "CCV" FEATURE OF WHICH MOST OF MY PRESENTATIONS OF ACTUAL FETAL MONITOR STRIPS ACTUALLY WORK? FOR THE "CCV" FEATURE TO BE EMPLOYED, KEEP IN MIND THAT WHEN THE MATERNAL HEART RATE IS ABOVE 100 AND THE FETAL MONITORS STARTS DETECTING COINCIDING MATERNAL AND FETAL HEART RATES IT WILL PRINT OUT "COINCIDENCE STATUS ON" BUT WILL AUDIBLY ALARM AND PRINT "COINCIDENCE" IF 80% OF A 1 MINUTE TIME FRAME OF MATERNAL AND FETUS ACTUALLY VISUALLY COINCIDE. BASICALLY THE MACHINE IS RECEIVING INPUT DATA THAT MOM AND BABY HEART RATES ARE THE SAME BUT THE ACTUAL PAPER COMING OUT OF THE MONITOR SEPARATES AND DELAYS THE FETAL AND MATERNAL HEART RATES SO IT WILL NEVER AUDIBLY ALARM OR VERY RARELY AUDIBLY ALARM AT THE NURSES STATION. WHEN ASKED PHILIPS ON 1/5/2010, IF A PATCH CAN BE PUT ON THEIR SYSTEM TO LINE UP AND COINCIDE THE 2 IDENTICAL HEART RATES, THE REPLY WAS, "NO". THE AVALON MONITOR BASICALLY KNOWS IT'S THE SAME HEART RATES BUT THE CCV SYSTEM PRINTS OUT 2 SEPARATE TRACINGS OF WHICH THEY ARE DELAYED AS WELL. SUSPECTED FETAL MONITOR FLAW #4: WHEN THERE IS AN ABSENCE OF BABY'S HEART RATE, THE MONITOR DOUBLES THE MOTHER'S HEART RATE. UPON SONOGRAM THE INFANT WAS WITHOUT FETAL HEART RATE ACTIVITY. THE MATERNAL PULSE OXIMETER WAS IN USE AS OUTLINED IN THE CLASS 2 RECALL DATED 11/20/2009. PHILIPS HEALTHCARE REP ON A PHONE CONVERSATION ON 1/5/2010, HAD NEVER HEARD OF THIS PHENOMENA. SUSPECTED FETAL MONITOR FLAW #5: THIS IS A DIFFICULT FLAW NOT REPORTED OR NOT DISCOVERED AND BROUGHT FORWARD YET TO THE FDA TO CAPTURE BUT THE FETAL MONITOR IS MONITORING TO THE BEST OF ITS ABILITY AND THEN SUDDENLY JUST STOPS WORKING ON ALL ASPECTS OF THE MONITOR. THE TOCO, THE ULTRASOUND TRANSDUCER, THE FETAL SCALP ELECTRODE, THE MATERNAL PULSE OXIMETER JUST STOP. MULTIPLE CABLES CHANGE OUTS ON A BRAND NEW SYSTEM TO KEEP THE MACHINE WORKING AND IRONICALLY NOT ALWAYS THE SAME MACHINE OF THE 7 WOULD JUST STOP WORKING. I WAS ABLE TO CAPTURE 3 EVENTS IN ALL AND RETAIN FOR DEMONSTRATION PURPOSES. WHAT I FOUND WITH ONE OF THE 3 EVENTS HOWEVER, WAS THAT WHEN THE TOCO CABLE WAS DISCONNECTED THE FETAL HEART RATE TRACING RETURNED. THIS LEADS ME TO FEEL THE TOCO CABLE IS POTENTIALLY CAUSING THIS TOCO ELECTRICAL FLAW.