Description of Event or Problem · 1
THANK YOU ONCE AGAIN FOR LOOKING AT THIS SUBMISSION WITH PT CHART NUMBER AS THE IDENTIFIER AT (B)(6) IN AN ATTEMPT TO CONTINUE SUPPORTING DATA FOR SCENARIO #2 AS PREVIOUSLY ENTERED. MR. (B)(6), DIRECTOR OF NURSING WOULD, I'M SURE, BE HAPPY TO ASSIST THE FDA WITH THE FETAL MONITORING STRIP AND NOTES FROM THE SYSTEM TO SUPPORT MY SUSPECTED CLAIMS OF POTENTIAL LIFE THREATENING FLAWS ON THE AVALON FM FETAL MONITORING SYSTEM BY PHILIPS HEALTHCARE. RECALL # Z-0552-2010. MR. (B)(6) CAN BE REACHED AT (B)(6). AT 1343, THE MONITOR'S CCV SYSTEM DETECTS THE MATERNAL HEART RATE ABOVE 100 AND ALERTS THE USER TO A POSSIBLE COINCIDENCE WITH THE FETAL HEART RATE. WHEN LOOKING AT 1343 ON THE FETAL MONITOR STRIP ITSELF, IT IS OBVIOUS THAT THIS COINCIDENCE OF MOTHER AND BABY'S HEART RATE IS TAKING PLACE. AT 1345, "COINCIDENCE STATUS ON" ALARMS AGAIN. NOTICED HOW THERE IS AT LEAST A 20 BEAT DIFFERENCE IN BASELINE THIS TIME. AT 1348, "COINCIDENCE STATUS ON" ALARMS AGAIN. IT IS SKETCHY HERE BUT THERE IS A 10-15 BEAT DIFFERENCE EXACTLY AS THE CLASS 2 RECALL OUTLINES THIS TIME. AT 1353, MIMICKING FEATURES OF THE MATERNAL BASELINE IS NOTED IN COMPARISON TO THE FETAL BASELINE. AT 1355, "COINCIDENCE STATUS ON" ALARMS AGAIN. THE BEAT DIFFERENCE BETWEEN MATERNAL AND FETAL HEART RATES IS APPROX A 10 BEAT DIFFERENCE. AT 1358, "COINCIDENCE STATUS ON" ALARMS AGAIN. THE BEAT DIFFERENCE MATERNAL AND FETAL HEART RATES IS APPROX UP TO A 20 BEAT DIFFERENCE BUT NOTICE OFF TO THE SIDE OF THE ACTUAL COMPUTER MONITOR NOTES IT READS: COINCIDENCE STATUS ON FHR 1 MODE: NO TRANSDUCERS TOCO MODE: NO TRANSDUCERS FHR 1 MODE: US FMP STATUS: ON. WHAT DOES ALL THAT MEAN? BASICALLY, THE MONITOR IS SAYING FROM THE READINGS I GATHER FROM THE ORIGINAL PHILIPS AVALON FETAL MONITOR MANUAL: I'M DETECTING SIMILAR MATERNAL AND FETAL HEART RATES. BUT I DETECT YOU ARE USING AN (US) ULTRASOUND TRANSDUCER TO PICK UP FETAL HEART RATE BUT NOW I DETECT NO TRANSDUCER -I'M ALSO SUDDENLY DETECTING THAT -TOCO- CONTRACTION EXTERNAL MONITOR TRANSDUCER IS GONE AS WELL =SO I HAVE SWITCHED ON -FMP STATUS- TO DETECT IF THE INFANT IS STILL MOVING. THIS IS CONFUSING BUT THE MONITOR IS CONTINUING TO TRACE WITH THE SAME ULTRASOUND AND CONTRACTION CABLES EVEN THOUGH THE COMPUTER IS DETECTING THAT THE CABLES ARE GONE. I SEE THIS QUITE FREQUENTLY IN UNEVENTFUL TRACINGS AND NOT THE SAME MONITOR. AT 1402, "COINCIDENCE STATUS ON" ALARMS WITH A SKETCHY ERRATIC BEAT DIFFERENCE BETWEEN THE MOTHER AND FETUS HEART RATES AND THEN DELIVERY OCCURS. AT 1405 AND 1407, NOTICE THE ULTRASOUND CABLE CONTINUES TO TRACE THE APPEARANCE OF A FETAL HEART RATE AFTER THE DELIVERY AS IN SCENARIO #1 THAT I SUBMITTED ON MONDAY (B)(6) 2011 - THE TRACING IN THE ABSENCE OF FETAL HEART TONES AS VERIFIED WITH A SONOGRAM- SO THE QUESTION IS RAISED HOW OFTEN DOES THIS COMPUTER SYSTEM READ THAT THE ULTRASOUND AND TOCO ARE GONE BUT YET IT STILL TRACES? I SEE IT QUITE OFTEN BUT HAVE NOT ACTUALLY CALCULATED % THAT IS OCCURRING OUT OF THE 200 OF THE 450 STRIPS I WAS ABLE TO REVIEW BEFORE SUBMITTING VOLUNTARY REPORTS TO THE FDA. ALSO, MY QUESTION IN WHAT CAPACITY DOES IT IMPACT IN POTENTIALLY NEGATIVE FETAL OUTCOME EVENTS? DATES OF USE: (B)(6) 2009 - (B)(6) 2010.