BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVALON FETAL MONITOR

    MDR report key: 2113350 · Received May 28, 2011

    Report

    Report Number
    MW5020826
    Event Type
    Malfunction
    Date Received
    May 28, 2011
    Date of Event
    October 26, 2009
    Report Date
    May 28, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    HGM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AK, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM RPTR (B)(4) 2011: FOLLOW UP REPORT TO THE PHILIPS AVALON FETAL MONITORS, I AM REFERENCING AS MY ACCESS NUMBER: (B)(4) FROM A LETTER I RECEIVED FROM (B)(4). DIVISION DIRECTOR, (B)(6) FOLLOW UP FROM 5 REPORTS I SUBMITTED TO MEDWATCH (B)(4). I WOULD LIKE TO TELL DR. (B)(4) THAT I HAVE 2 EMAILS DATED (B)(6) 2010 THAT A CONVERSATION OCCURRED WITH (B)(6), LEAD APPLICATION SPECIALIST ON (B)(6) 2010 FROM PHILIPS HEALTHCARE OF WHICH PROBLEMS NOT OUTLINED WITH THE RECALL NUMBER Z-055-2010 NOT LISTED IN THE CLASS 2 RECALL WAS DISCUSSED OVER THE TELEPHONE. CASE NUMBER AT PHILIPS THAT WAS ASSIGNED WAS (B)(4). PRIOR TO PHILIPS GIVING THE FACILITY (B)(6) A FULL REFUND, NO QUESTIONS ASKED FROM PHILIPS HEALTHCARE INC FOR THE RETURN OF THE PREVIOUSLY PURCHASED 7 AVALON FM 50 FETAL MONITORS BY THE FACILITY. THERE ARE EMAILS CONTAINING 11 PERTINENT DISCLOSING QUESTIONS AND MY FOLLOW UP IN EMAIL FORM OF THAT CONVERSATION THAT OCCURRED ON (B)(6) 2010 WITH LEAD APPLICATION SPECIALIST, (B)(6). I HAVE COPIES OF THESE EMAILS AND I AM COMING TO (B)(6) ON (B)(6) 2011 IF THEY ARE OF INTEREST TO DR (B)(6). I WAS GIVEN THE ACCESS NUMBER OF (B)(4) BUT IT IS UNCLEAR IF THIS IS THE CORRECT ROUTE TO CORRESPOND WITH THIS INFO. SN# (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFO RECEIVED FROM THE REPORTER ON 12/24/2013: THIS REPORT IS A FOLLOW UP REPORT TO REPORTS I MADE TO THE FDA IN 2011. I FEEL DEEPLY COMMITTED AS I HAVE STUDIED THE AVALON FETAL MONITORING SYS FOR 4 YEARS NOW AND WITH 22 YEARS OF LABOR AND DELIVERY EXPERIENCE, I HAVE BECOME AN EXPERT ON THE AVALON FETAL MONITORING SYS. THIS REPORT IS A CULMINATION OF SOME OF THE INFO I FOUND REGARDING THE PHILIPS AVALON FETAL MONITORING SYS ON THE MAUDE WEBSITE. I WAS SO THANKFUL TO SEE THAT THE ORIGINAL PROGRAM WRITER FROM (B)(4) HAD DEVELOPED AN UPGRADE 3/18/2011 AND FIELD ORDER TO UPGRADE ALL THE UNITS IN MAY OF 2011. TESTING IN AUGUST 2011 SHOWED "THAT THE MATERNAL PULSE RATE OBTAINED FROM THE TOCO MP TRANSDUCER HAS BEEN RECORDED TOGETHER WITH THE ECG DERIVED MATERNAL HEART RATE." FROM THAT REPORT IN AUGUST OF 2011, IT APPEARS THAT THE FETAL HEART RATE WAS ACCURATE NOW COMPARED TO THE MATERNAL HEART RATE AS PREVIOUSLY STATED IN THE CLASS 2 RECALLS IN SEPTEMBER OF 2009. I STILL HAVE CONCERNS ABOUT THE FETAL SCALP ELECTRODE INACCURACIES LEADING TO AN UNNECESSARY CESAREAN SECTION MAY HAVE BEEN PERFORMED DUE TO THE FETAL SPIRAL ELECTRODE AS WELL. SO MY QUESTION HERE IS: WAS THIS FETAL MONITORING UNIT ALREADY SERVICED WITH THE FIELD ORDER TO UPGRADE ALL THE UNITS IN MAY OF 2011? IF SO, THEN PLEASE REFER TO REPORT #(B)(4) AND REPORT #9610816-2011-00335 TO SEE IF THE CCV SYSTEM WAS EMPLOYED IN BOTH SYSTEMS AFTER MATERNAL HEART RATE IN BOTH REPORTS IS GREATER THAN 100 BEATS PER MINUTE AND DOES THE "CCV" DERIVED FETAL SCALP ELECTRODE MONITOR TRACINGS HAVE ALSO BEEN CORRECTED IN THAT AUGUST 2011 REPORT? IN THE CLASS 2 RECALL, DATED 09/04/2009, PHILIPS DID AN EXCELLENT JOB AT EMPHASIZING CONFIRMATION OF FETAL LIFE BY USE OF DOPPLER, FETOSCOPE ULTRASOUND AND FETAL SPIRAL ELECTRODE. IN THE NEXT SERIES OF MAUDE REPORTS THAT I WILL LIST, PLEASE NOTE THAT THEY ARE SIMILAR REPORTS IN THAT THE SAME ISSUES ARE CLAIMED WITH FETAL SPIRAL ELECTRODES IN THE CASES OF DEMISE FETUSES AND UNNECESSARY CAESAREAN SECTIONS DUE TO FETAL SPIRAL ELECTRODE INACCURACIES, HAVE THESE FETAL MONITOR TRACINGS BEEN DETERMINED THAT THE "CCV" SYSTEM IS EMPLOYED DURING THE USE OF THE FETAL SPIRAL ELECTRODE IN EACH REPORT? PLEASE NOTE THAT THESE ARE JUST SOME OF SUCH EVENTS ON THE MAUDE WEBSITE. MANY OF SUCH OCCURRENCES MAY HAVE NEVER BEEN REPORTED TO THE FDA AS THESE TYPES OF DELIVERIES ARE USUALLY RECORDED AS IUFD (INTRAUTERINE FETAL DEMISE). I BELIEVE THAT THERE ARE HUNDREDS OF NOT THOUSANDS OF THESE TYPES OF DELIVERIES SINCE THE 1970'S. THESE EVENTS ARE WHERE A SPIRAL ELECTRODE HAS REGISTERED A NONVIABLE FETAL HEART RATE THROUGH A DEAD FETUS THAT IS ACTUALLY RECORDING THE MOTHER'S HEART RATE USING ANY FETAL MONITORING SYSTEM, NOT JUST THE PHILIPS AVALON FETAL MONITORING SYSTEM. REPORT NUMBER, REPORT DATE: 9610816-2013-00131, 06/13/2013; 9610816-2009-00205, 08/12/2009; 9610816-2009-00206, 10/19/2009; 9610816-2010-00042, 01/07/2010; 9610816-2011-00335, 05/27/2011; 9610816-2011-00345, 06/08/2011; 9610816-2005-00113, 04/01/2005; 9610816-2005-00115, 04/01/2005; 9610816-2006-00115, 03/08/2006; 9610816-2006-00244, 07/05/2006. ANOTHER QUESTION I HAVE IS IF THE SPIRAL ELECTRODE COMPONENT OF THE AVALON FETAL MONITORING SYSTEM HAS THE PATENT TO THE SPIRAL ELECTRODE WITH ANOTHER COMPANY? OR PHILIPS?. AS THE PREVIOUS COMPANY (B)(4) DID NOT HAVE THE PATENT TO THE SPIRAL ELECTRODE IN 1991, MY PERSONAL VERY FIRST FETAL MONITORING CLASS. IF SO, ARE THE FLAWS IN THIS SEPARATE COMPONENT NOT OWNED BY PHILIPS? IT IS DEFINITELY CLEAR IN THE MAUDE REPORTS THAT PHILIPS IS MAKING EVERY EFFORT TO IMPROVE THE ACCURACY OF THEIR AVALON FETAL MONITORING SYS. I FEEL THAT PHILIPS IS NOT ALWAYS TO BLAME IN THOSE REPORTS FOR THE FETAL DEATHS DESCRIBED IN THOSE SAMPLE MAUDE REPORTS. BUT RATHER THAT SOME OF THOSE FETAL DEATHS ARE PERHAPS A PHENOMENA WHERE THE FETUS IS NOT ALIVE BUT UPON PLACING A FETAL SPIRAL ELECTRODE ON A DEAD FETUS, OUR TECHNOLOGY IS ADVANCED TO THE POINT IT WILL SEARCH FOR A BABY HEART RATE AND THEN REGISTER MOM'S HEART RATE AS IT IS THE ONLY HEART RATE THE FETAL SCALP ELECTRODE DETECTS. I HAD THE EXPERIENCE OF HAVING A FETAL SPIRAL ELECTRODE REGISTER THROUGH AN UNBORN DEAD BABY AND REGISTER THE MOTHER'S HEART RATE. THERE WAS NO CONFIRMATION OF FETAL HEART TONES AS THIS IS NOT COMMON PRACTICE EVEN THOSE MANY YEARS AGO. EVEN THOSE BABIES NOT YET DEAD BUT WITH A HEART RATE LESS THAN 30.. THE FETAL SPIRAL ELECTRODE WILL NOT PICK UP THE FETAL HEART RATE LESS THAN 30. BUT IF DETECTED AN EMERGENCY CESAREAN SECTION COULD SAVE A BABIES LIFE JUST BY VERIFYING THE BABY HEART RATE WITH DOPPLER, ULTRASOUND, OR FETOSCOPE. IN DEFENSE FOR PHILIPS THEY SHOULD NOT BE ACCOUNTABLE FOR THE LACK OF CONFIRMATION OF FETAL LIFE BEFORE EVEN TURNING ON THE PHILIPS AVALON FETAL MONITORING SYSTEM AMONG THE CLINICIANS WHICH ARE MANY THAT DON'T PRACTICE CONFIRMATION OF FETAL LIFE. THROUGH THE USE OF ORGANIZATIONS THAT TEACH FETAL MONITORING SUCH AS (B)(6), INFANT LIVES COULD BE SAVED AS UPON PLACING A SPIRAL ELECTRODE ON ANY FETUSES THAT IT MUST BE 100% VERIFIED WITH DOPPLER, ULTRASOUND OR FETOSCOPE. THIS IS NOT HOW CLINICIANS CURRENTLY PRACTICE. WE RELY ON MACHINES TOO MUCH TO TELL US AN INFANTS STATUS. THE EFFECTS OF SUCH AN EVENT ON THE FAMILY IS DEVASTATING TO BE IN LABOR FOR HOURS THINKING YOU HAVE A LIVE BABY ONLY TO FIND OUT YOUR BABY IS DEAD WHEN IT'S BORN. ALSO TO THE CLINICIANS THAT MAY HAVE PTSD AFTER SUCH AN EVENT. WHEN I USE THE WORD CLINICIANS THROUGHOUT THIS REPORT.. THESE NEW STANDARD OF CARE SUGGESTIONS ARE FOR NOT JUST HOSPITALS BUT HOME BIRTHS AND MIDWIFE BIRTHING CENTERS AS WELL AS ACROSS OUR NATION BUT GLOBALLY AS WELL. THROUGH THE USE OF FETAL MONITOR INSTRUCTORS, ORGANIZATIONS SUCH AS (B)(6) AND PERHAPS PHILIPS COULD AID IN EDUCATING CLINICIANS ACROSS THE NATION TO BRING UP THE STANDARD OF CARE TO PREVENT THESE SITUATIONS FROM REPEATING. (B)(6) COULD TAKE THE INITIATIVE LIKE THE SUCCESSFUL 39 WEEK INITIATIVE, BECAUSE IT'S ALL ABOUT SAVING INFANT LIVES. SIMPLY BY CONFIRMING FETAL HEART RATE BY USING 2 METHODS NOT JUST ONE TECHNOLOGY. BEFORE EVER PLACING MOM ON EXTERNAL FETAL MONITOR AND VERIFY AGAIN IF INTERNAL FETAL SCALP ELECTRODE IS PLACED. VERIFY 100% OF TIME WHEN INTERNAL FETAL SCALP ELECTRODE IS PLACED. MATERNAL PULSE OXIMETER USED 100% OF TIME WHICH IS NOT ALWAYS DONE IN LABOR. CONSIDER VERIFYING EACH TIME PT OFF MONITOR. A POSITIVE CHANGE AS WE ADVANCE IN OUR TECHNOLOGY AND COMPANIES SUCH AS PHILIPS WORK DILIGENTLY TO CORRECT FLAWS IN THEIR NEW "CCV" TECHNOLOGY. ANY CLINICIAN IF YOU ASK THEM AND TELL THEM THAT JUST ONE INFANT COULD BE SAVED THIS WAY BY VERIFYING FETAL HEART TONES WITH 2 METHODS INSTEAD OF ONE, ANY CLINICIAN WOULD IMPROVE THEIR FETAL MONITORING PRACTICES IMMEDIATELY. THE EMPHASIS JUST NEEDS TO BE HEARD. WHAT BETTER WAY THAN THROUGH THE FDA. AS CLINICIAN WE ARE ALL DOING WHAT WE LOVE TO DO. TO BRING NEW LIFE TO THIS WORLD SAFELY BECAUSE THESE BABIES IN THEIR OWN WAY TOUCH OUR HEARTS AND LIFE IS PRECIOUS AND SO ARE THEY. WAS TRYING TO LINK THIS REPORT TO ONE I MADE IN 2011. (B)(4) IS THE ACCESS NUMBER.

    Description of Event or Problem · 1

    THANK YOU FOR CONTINUING TO LOOK INTO THIS EVENT. THIS EVENT IS ENTERED AS TO SUPPORT SCENARIO #2 AS PREVIOUSLY SUBMITTED. PT IDENTIFIER IS PT'S CHART NUMBER AT (B)(6) IN (B)(6). AGAIN, I AM UNABLE TO SEND THE ACTUAL FETAL MONITOR COMPUTER GENERATED STRIP OR THE NOTES IN THE FETAL MONITOR COMPUTER OR ANYTHING FROM THE ACTUAL PT'S CHART. PLEASE CONTACT (B)(6), DIRECTOR OF NURSING AS I'M SURE HE WOULD BE HAPPY TO ASSIST THE FDA WITH IDENTIFYING A POTENTIALLY SEVERELY FLAWED POTENTIALLY LIFE THREATENING FETAL MONITORING SYSTEM TO THE FDA OF POTENTIAL FLAWS NOT MENTIONED IN THE CLASS 2 RECALL ISSUED BY THE FDA (RECALL # Z-0552-2010). (B)(6) CAN BE REACHED AT (B)(6). I WILL CALL THIS SCENARIO #3 TO SUPPORT THE POTENTIAL LIFE THREATENING FLAWS AS DISCUSSED IN SCENARIO #2. IN THIS EXAMPLE, A FETAL SCALP ELECTRODE IS USED AS OUTLINED IN THE CLASS 2 RECALL ON PAGE ONE AND PAGE 2 TO VERIFY FETAL HEART TONES. FROM 1645 UNTIL OFF THE MONITOR AT 1711, THIS IS WHAT APPEARS TO BE A NORMAL LOOKING FETAL MONITOR STRIP THAT IS UNEVENTFUL. BUT UPON PLACING THE PT BACK ON THE FETAL MONITOR, THERE IS ERRATIC SIGNALS FROM THE ULTRASOUND TRANSDUCER. AT 1740-1741, A FETAL SCALP ELECTRODE WAS PLACED AS OUTLINED AT THE TOP OF PAGE 2 OF THE PHILIPS CLASS 2 RECALL. AT 1745, NOTICE HOW THE SCALP ELECTRODE WAS REGISTERING A FETAL HEART RATE 140-150'S THEN SUDDENLY DROPS TO MATERNAL HEART RATE. HOWEVER, AN INTERESTING FEATURE OCCURS. NOTICED AT 1746 AND 1748 HOW THE FETAL HEART RATE TRACING MIMICKS THE MATERNAL HEART RATE WITH AT LEAST A 20 BEAT DIFFERENCE FROM THE MATERNAL HEART RATE THAT IS IN THE 60'S WHICH IS WHY THE CCV SYSTEM WAS NEVER ENABLED. -BECAUSE MOM'S PULSE WAS BELOW 100- AT 1752, IT IS OBVIOUS THE -FSE- FETAL SCALP ELECTRODE IS PICKING UP A GOOD FETAL SIGNAL AND GOES ON TO DELIVER W/O INCIDENT. SO THIS REINFORCES THE QUESTION AGAIN. DOES THE CCV SYSTEM BECOME DISABLED OR CONTINUE TO BE ENABLED WHEN A FETAL SCALP ELECTRODE IS USED BECAUSE NOWHERE IN THE MANUAL OR CLASS 2 RECALL IS THIS QUESTION ANSWERED? ALSO, WHEN IT IS CLEAR THAT THE "CCV" SYSTEM IS NOT ENABLED AS WHEN THE MATERNAL HEART RATE WAS IN THE 60'S-NOT ABOVE 100 TO EMPLOY THE CCV SYSTEM- THERE IS A CLEAR 20 BEAT MIMICKING SEPARATION WITH THE VERIFICATION OF FETAL HEART TONES WITH A FETAL SCALP ELECTRODE, SO AS TO CLEARLY UNDERSTAND THAT GREATER THAN THE CLASS 2 RECALL DISCUSSED 10-15 BEAT DIFFERENCE ON PAGE ONE OF THE CLASS 2 RECALL, CAN ACTUALLY BE GREATER WHETHER THE "CCV" SYSTEM IS ENABLED OR NOT? DATES OF USE: (B)(6) 2009 - (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVALON FETAL MONITOR FM 50 FETAL MONITOR HGM PHILIPS HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Other