Description of Event or Problem · 0
THE MAJORITY OF THE FETAL MONITORING EQUIPMENT CURRENTLY USED AT HOSPITALS/CLINICS, IRRESPECTIVE OF THE MAKE AND MODEL, HAVE INHERENT FLAWS THAT RESULT SPURIOUSLY/INTERMITTENTLY FALSE FETAL HEART RATE (FHR) READINGS. THERE ARE TEN MAJOR ROOT CAUSES OF SPURIOUSLY FALSE FHR TRACING. AS THE TRANSDUCERS AGE, THE FREQUENCY OF THE SPURIOUS FHR RESPONSE GETS DOMINANT DUE TO MULTIPLE MECHANICAL STABILITY ISSUES WITH ITS INTERNAL COMPONENTS AS WELL AS ELECTRICAL CIRCUIT FUNCTIONAL FLAWS. THE ULTRASOUND BEAM TRANSMISSION QUALITY DETERIORATES OVER A PERIOD THAT RESULTS IN REDUCED/POOR SIGNAL TO NOISE RATIO AS ONE OF THE MAJOR ROOT CAUSE FOR THE SPORADICALLY INACCURATE FHR THAT, AT TIMES, PROMINENTLY REPRESENTS MOTHER'S HEART RATE (MHR) AS THE RELATIVELY STRONGER DOPPLER SIGNAL FROM THE BLOOD FLOW IN MOTHER'S VESSELS BECOME THE PRIMARY SIGNAL AGAINST THE VERY WEAK (LOWER AMPLITUDE) DOPPLER SIGNAL FROM THE FETUS HEART DUE TO SIGNIFICANTLY LOWER TRANSMITTED ULTRASOUND BEAM INTENSITY THAN THE OEM SPECIFIED FOR THE RELIABLE DOPPLER SIGNAL ACQUISITION FROM THE BEATING FETAL HEART. WHEN THE TRANSMITTED ULTRASOUND BEAM QUALITY GETS EXTREMELY POOR, THE DOPPLER SIGNALS FROM MOTHER'S BLOOD VESSELS AS WELL AS FROM THE FETAL HEART ARE SIGNIFICANTLY LOW IN AMPLITUDE (POWER) FOR THE PROCESSING CIRCUIT TO DETECT AND HENCE THE RANDOM NOISE BECOMES THE MAIN/PRIMARY SOURCE ALONG WITH THE VERY THE STRONG UNDESIRED DOPPLER SIGNAL FROM TRANSDUCERS INTERNAL SURFACE DUE TO LOOSE CRYSTALS (PZT DISCS)/AIR GAP IN THE BONDING LAYER, IN WHICH CASE, THE FALSE FHR READING THAT CLOSELY MATCHES TO ACTUAL HEART RATE OF THE MOTHER (MHR), IS A SHEER COINCIDENCE AND IS WRONGLY ATTRIBUTED TO THE LIMITATION OF THE FETAL ULTRASOUND DOPPLER TECHNOLOGY IF THE THOROUGH TESTING FOR THE ULTRASOUND BEAM TRANSMISSION QUALITY IS NOT PERFORMED AFTER THE ADVERSE EVENT INVOLVING INJURY AND DEATH. IN CASE OF ALL THE MODELS OF WIRED PHILIPS AVALON FETAL ULTRASOUND TRANSDUCERS, INTERMITTENT OR CONTINUOUS OPEN CIRCUIT OF A SINGLE INPUT TO THE LVDS (LOW VOLTAGE DIFFERENTIAL SIGNALING) AMPLIFIER DUE TO THE STRESS ON CABLE-CONNECTOR DURING USE ON THE EXPECTANT MOM/PATIENT, THE ULTRASOUND BEAM IS NOT AT ALL TRANSMITTED BUT THE RANDOM NOISE (INTERNAL TO THE TRANSDUCER CIRCUIT) IS PROCESSED TO GIVE A TOTALLY FALSE FHR TRACING. NO TRANSMISSION OF THE ULTRASOUND BEAM MEANS THERE IS NO DOPPLER ECHO SIGNAL OR NO ORGAN, NEITHER MOTHER'S BLOOD VESSEL NOR FETUS HEART, IS SENSED AT ALL BUT THE FALSE FHR READINGS ARE PRODUCED. AGAIN, IF THE SPURIOUS FHR READING MATCHES WITH THE ACTUAL MHR WHEN LVDS SINGLE INPUT IS OPEN CIRCUIT, IT IS WRONGLY ATTRIBUTED TO THE LIMITATION OF THE FETAL ULTRASOUND DOPPLER TECHNOLOGY. TO MAKE IT CLEARER, WHEN A SINGLE CONNECTION OPEN CIRCUIT (HIGH IMPEDANCE STATE) OCCURS INTERMITTENTLY OR CONTINUOUSLY AT THE LVDS INPUT, THE TRANSDUCER RECORDS TOTALLY FALSE FHR WITHOUT EVEN ACTUALLY USING IT ON THE EXPECTANT MOM/PATIENT. IT COULD EXPLAIN AS TO WHY CLINICIANS GET VERY SURPRISED IN SOME CASES AFTER FINDING BABY DEAD AT THE BIRTH (STILLBIRTH) EVEN THOUGH THEY HAD STRICTLY FOLLOWED OEM INSTRUCTIONS AND CONFIRMED THE FETUS BEING LIVE BY USING ULTRASOUND IMAGE SCANNER BEFORE STARTING THE MONITORING EVENT AND FHR TRACING OF THE MONITORING EVENT SHOWING NO SIGNS OF LOSS OF LIFE FROM START OF THE MONITORING EVENT TILL THE BIRTH. DUE TO MULTIPLE INHERENT FLAWS, THE FHR TRACING SHOWS FALSE HEART RATE IN HIGH RANGE ABOVE 200 BPM OR VERY LOW BELOW 100 BPM EVEN WHEN THE ACTUAL FHR IS IN THE NORMAL (120 TO 160 BPM) RANGE IN SOME CASES PROMPTING UNNECESSARY INTERVENTION SUCH AS C-SECTION. ON THE OTHER HAND, NORMAL FHR TRACING IS PRODUCED IN SOME CASES THOUGH THE FETUS IS UNDER STRESS WITH VERY HIGH FHR CLOSE TO 240 BPM OR ACTUAL FHR HAS DROPPED BELOW 100 BPM AND THE EQUIPMENT CONTINUE PROVIDING NORMAL FHR TRACE WITHOUT ANY ALARMS (LOW/HIGH FHR) TO PROMPT CLINICAL USERS EVEN WHEN THE FETUS HAS DIED AFTER GOING THROUGH THE STRESS. IT IS EXTREMELY IMPORTANT THAT THE FETAL MONITOR WITH THE TRANSDUCERS TO BE THOROUGHLY TESTED ROUTINELY AND ESPECIALLY IMMEDIATELY AFTER THE ADVERSE EVENT, FOR ALL THE FUNCTIONAL PARAMETERS TO RESPECTIVE OEM SPECIFICATIONS THAT INCLUDE THE ULTRASOUND TRANSMISSION BEAM QUALITY AS WELL AS THE RELIABILITY OF THE AUTOCORRELATION DETECTION ALGORITHM EXECUTION (FIRMWARE) FOR THE FHR ACCURACY TO RULE OUT THE EQUIPMENT WITH SPURIOUSLY FALSE RESPONSE AS THE ROOT CAUSE OF THE ADVERSE EVENT. NOT A SINGLE REPORT OF FULL TESTING TO PUBLISHED OEM SPECIFICATION IS AVAILABLE FOR THE ASSOCIATED FETAL MONITOR EQUIPMENT FOR ANY OF THE ADVERSE EVENTS RELATED TO LABOR REPORTED OVER PAST 15 YEARS ON THE FDA SITE IN ORDER TO SUPPORT THE OEM/MANUFACTURER'S NARRATIVE STATING THE DEVICE FUNCTIONED PERFECTLY TO THEIR OWN DESIGN SPECIFICATIONS. ALL THE MAKE AND MODELS OF THE TOCO TRANSDUCERS, THE TESTING PROCEDURE RECOMMENDED AND MENTIONED IN THE RESPECTIVE OEM FETAL MONITOR MANUALS IS INADEQUATE TO ENSURE THE RELIABLE CONTRACTION SENSING ABILITY AS ALL THE FUNCTIONAL PARAMETERS (DYNAMIC RANGE, SENSITIVITY, OUTPUT DRIFT) ARE NOT EVER FULLY CHECKED OR GUARANTEED. THE TOCO TRANSDUCER UNIT TO UNIT SENSITIVITY VARIES SIGNIFICANTLY AND DUE TO VERY POOR SENSITIVITY BEYOND THE RANGE OF INITIAL APPLIED PRESSURE OF BELT WHEN IT IS STRAPPED TO THE BELLY, THE TRANSDUCER MISSES DETECTION OF LOW TO MEDIUM STRENGTH CONTRACTION IN SOME MONITORING EVENTS AND PROVES TO BE FATAL WHEN THE OXYTOCIN IS ADMINISTERED FOR THE LABOR INDUCTION. ALL THE GE COROMETRICS NAUTILUS TOCO TRANSDUCER MODELS HAVE MANY DESIGN FLAWS RESULTING IN MOST UNRELIABLE FUNCTIONALITY WITH SPURIOUS OUTPUT RESPONSE. PHILIPS AVALON TOCO TRANSDUCERS M2734A, M2734B AND M2735A, AS THEY AGE, GO THROUGH INTERMITTENT POWER RESET ON THEIR OWN MAKING CONTRACTION TRACING FLAT. THE CLINICALLY IMPORTANT INFORMATION OF DELAYED FHR DECELERATIONS IS MISSED IN THE ABSENCE OF THE LOW TO MEDIUM STRENGTH CONTRACTIONS DUE TO THE POOR TOCO SENSITIVITY. THE OEM FETAL MONITORING TRANSDUCERS HAVE INHERENT DESIGN FLAWS THAT RESULT SPURIOUS FHR TRACING AND DEGRADES CLINICAL THROUGHPUT OVER A TIME. THE THIRD-PARTY REPAIRED AND REFURBISHED FETAL TRANSDUCERS MAKE IT WORSE, CONTRIBUTING TO THE SIGNIFICANT INCREASE IN UNNECESSARY INTERVENTIONS SUCH AS C-SECTIONS AS WELL AS ADVERSE EVENTS. ALMOST 100% OF THE REPAIRED/REFURBISHED TRANSDUCERS WITH TAG MARKS 'PRTS---', 'NPC-- -', 'NFPHA ---', 'QUBM---' ETC. ARE NON-COMPLIANT WITH THE PUBLISHED OEM SPECIFICATIONS FROM THE DAY ONE AFTER THE REPAIRS. ALL THESE FAULTY TRANSDUCERS WITH SPURIOUS FUNCTIONAL PERFORMANCE ELUDE BEING DETECTED IN ABSENCE OF THE THOROUGH TESTING TO OEM SPECIFICATIONS. SOME OF THE GENERAL LIABILITY INSURANCE CARRIERS FOR HOSPITALS AS WELL AS THE HEALTH INSURANCE CARRIER FOR PATIENTS HAVE STARTED TAKING NOTE OF ALL THESE FACTS AND THEIR AUDITS WILL HELP TO EDUCATE THE CLINICAL END USERS BUT SOME KIND OF REGULATION WOULD BE A BETTER SOLUTION. PLEASE REFER TO THE ATTACHED DOCUMENT THAT EXPLAINS ALL THE FLAWS WITH THE OEM FETAL MONITOR EQUIPMENT AND BELOW LINKS TO THE RECENTLY AWARDED PATENTS FOR BETTER UNDERSTANDING. (B)(4). WE WOULD REQUEST THE FDA OFFICIALS TO CONFIRM WHETHER THE DETAILED REPORTS WITH FULL TESTING TO THE RESPECTIVE OEM SPECIFICATIONS OF ASSOCIATED FETAL MONITOR WITH TRANSDUCERS AFTER THE ADVERSE EVENTS OF INJURY, DEATHS REPORTED ON FDA WEBSITE SO FAR, ARE AVAILABLE. IF SO, KINDLY GUIDE US AS TO HOW TO ACCESS THAT INFORMATION FROM THE FDA WEBSITE OR THE PROCEDURE TO BE FOLLOWED IN ORDER TO SEEK IT.