Avalon Fetal Monitor FM30 Avalon FM30 Fetal MonitorRecalls & reported problems

Summary

The FDA's MAUDE database contains 142 adverse event reports that list this exact device (DI 00884838000414), received between Nov 28, 2017 and Jul 21, 2026 — classified as 11 deaths, 14 injuries, 117 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (39 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. May 26, 2026Class IIOpen, Classified

   Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or permanent loss of speaker output.

   Z-2523-2026 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 142 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 21, 2026No Audible Alarm

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25892472 ↗
• InjuryFeb 27, 2026False Positive Result

  PHILIPS RECEIVED A COMPLAINT ON THE AVALON FM30 FETAL MONITOR INDICATING THE USER CONFUSED THE MATERNAL AND FETAL HEART RATES, WHICH LED TO AN INTERPRETATION THE FETUS WAS IN BETTER CONDITION THAN IT WAS. A FETAL SCALP ELECTRODE WAS APPLIED, REVEALING THE HEART RATES WERE LIKELY MISINTERPRETED. IT WAS INDICATED THERE WAS HARM TO THE PATIENT. ADDITIONAL INFORMATION INDICATED THE BABY WAS BORN VIA C-SECTION WITH AN UMBILICAL ARTERIAL PH OF 6.75, APGAR SCORES OF 3-4-4, AND A HEART RATE OF 40BPM. AT 8 MINUTES OF AGE, THE PATIENT WAS THEN INTUBATED AND THERAPEUTIC HYPOTHERMIA WAS INITIATED DUE TO PERINATAL ASPHYXIA AND SIGNS OF NEUROLOGICAL IMPAIRMENT. SUBSEQUENT MRI OF THE BRAIN REVEALED EXTENSIVE ISCHEMIC CHANGES INVOLVING THE DEEP CENTRAL STRUCTURES OF THE CEREBRAL CORTEX.

  Patient problems: Insufficient Information

  MAUDE report 24475248 ↗
• InjuryFeb 27, 2026Incorrect Measurement

  IT WAS REPORTED THE USER CONFUSED THE MATERNAL AND FETAL HEART RATES, WHICH LED THE PHYSICIAN TO INTERPRET THE CTG TRACING AS BETTER THAN THE ACTUAL CONDITION OF THE FETUS. FROM 1240-1255, THE MONITOR TRACE DISPLAYED THE FETAL HEART RATE (FHR) BUT NOT THE MATERNAL HEART RATE (FHR); HOWEVER, THE PHYSICIAN BELIEVES THE MONITOR WAS ACTUALLY CAPTURING MHR. IT WAS ALSO NOTED THAT THE FHR AND MHR WERE AT THE SAME BASE RATE, BUT THE PATTERN OF FETAL HEART SOUNDS DIFFERED. BASED ON THIS INFORMATION, THE PHYSICIAN CONCLUDED THE DISPLAYED HEART RATE WAS ACTUALLY THE MHR AND NOT THE FHR. FOLLOWING DELIVERY OF THE BABY, THE BABY'S UMBILICAL CORD PH WAS 6.90, WHICH REFLECTS ACIDOSIS. ADDITIONAL INFORMATION INDICATED THE USER CONFUSED THE MATERNAL AND FETAL HEART RATES, WHICH LED TO AN INTERPRETATION THE FETUS WAS IN BETTER CONDITION THAN IT WAS. A FETAL SCALP ELECTRODE WAS APPLIED, REVEALING THE HEART RATES WERE LIKELY MISINTERPRETED. THE UMBILICAL ARTERY HAD A PH OF 6.91 AT BIRTH WITH APGARS OF 2-9-9. POSITIVE PRESSURE VENTILATION WAS ADMINISTERED FOR 3 MINUTES, AFTER WHICH THE INFANT RECOVERED AND WAS FED A 20ML BOTTLE OF FORMULA. THE EVENT WAS ASSESSED AS A TRANSIENT PERINATAL ASPHYXIA EPISO

  Patient problems: Insufficient Information; Respiratory Acidosis

  MAUDE report 24475093 ↗
• MalfunctionJan 23, 2026High Readings

  IT WAS REPORTED THAT THE VCT (SHORT TERM VARIATION) RESULTS ARE INCONSISTENT AND TOO HIGH. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24161060 ↗
• MalfunctionJan 21, 2026Incorrect Measurement

  PHILIPS RECEIVED A COMPLAINT ON AN AVALON FM30 FETAL MONITOR INDICATING THAT THE MONITOR SHOWED A DROP IN THE BABY'S HEARTRATE ON SEVERAL RECORDINGS DURING FETAL MONITORING. THE RATE DROPPED FROM 150 TO 62 BPM AND FROM 120 TO 90 BPM FOR NO APPARENT REASON. THIS OCCURRED SEVERAL TIMES. THE DEVICE WAS IN USE ON A PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24133019 ↗
• MalfunctionJan 7, 2026Imprecise or Erratic Results

  PHILIPS RECEIVED A COMPLAINT ON THE AVALON FM30 FETAL MONITOR INDICATING THAT THE DEVICE COULD NOT ACCURATELY MEASURE THE PULSE OF PREGNANT WOMEN AND THEIR FETUSES. THE DEVICE WAS IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23993169 ↗
• MalfunctionDec 24, 2025No Audible Alarm; No Audible Alarm

  PHILIPS RECEIVED A COMPLAINT ON THE AVALON FM30 FETAL MONITOR INDICATING THAT THE AUDIO OF THE EQUIPMENT IS NOT HEARD. THE DEVICE WAS IN CLINICAL USE. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888665 ↗
• MalfunctionNov 17, 2025Defective Alarm; Defective Alarm

  PHILIPS RECEIVED A COMPLAINT ON AN AVALON FM30 FETAL MONITOR INDICATING THAT THERE WAS AN ALARM MALFUNCTION. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. NO ADVERSE EVENT OR HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569141 ↗
• MalfunctionOct 28, 2025Incorrect Measurement; Incorrect Measurement

  PHILIPS RECEIVED A COMPLAINT ON AN AVALON FM30 FETAL MONITOR INDICATING THAT THE MONITOR REPORTS A FETAL HEART RATE THAT DOES NOT CORRESPOND TO THE AUSCULTATED HEART RATE AND CONSEQUENTLY MARKS ALARM CONTINUOUSLY. THE DEVICE WAS IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO ADVERSE EVENT OR PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23403601 ↗
• MalfunctionAug 25, 2025No Audible Alarm; No Audible Alarm

  THE CUSTOMER REPORTED THE AVALON FM30 FETAL MONITOR DISPLAYS A SPEAKER MALFUNCTION INOP ERROR MESSAGE DURING THE START UP OF THE DEVICE AND DOES NOT EMIT AUDIBLE SOUND. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22883436 ↗
• MalfunctionJul 16, 2025No Audible Alarm; No Audible Alarm

  IT WAS REPORTED THE AVALON FM30 FETAL MONITOR DISPLAYS A SPEAKER MALFUNCTION INOP ERROR AND HAS NO SOUND. THE DEVICE WAS NOT IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22518045 ↗
• MalfunctionMay 7, 2025Incorrect Measurement; Incorrect Measurement

  PHILIPS RECEIVED A COMPLAINT ON THE AVALON FM30 FETAL MONITOR INDICATING THAT, WHEN IN USE WITH THE TOCO SENSOR, THE VALUES ARE NOT RELIABLE. SOMETIMES THE VALUE GOES UP WHEN MOVING THE CABLE. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21980277 ↗
• MalfunctionMay 5, 2025No Audible Alarm; No Audible Alarm

  PHILIPS RECEIVED A COMPLAINT ON THE AVALON FM30 FETAL MONITOR INDICATING THERE IS NO SOUND FROM THE DEVICE AND SHOWS THE MESSAGE SPEAKER EQUIPMENT MALFUNCTION. THE DEVICE WAS IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21960680 ↗
• MalfunctionApr 28, 2025No Audible Alarm; No Audible Alarm

  IT WAS REPORTED THAT THE AVALON FETAL MONITOR FM30 INDICATING BEDSIDE ALARM NO AUDIO. THE DEVICE WAS NOT IN USE AT THE TIME OF THE REPORTED EVENT AND NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919206 ↗
• InjuryMar 26, 2025Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THE BLOOD PRESSURE CUFF WAS OVERINFLATING, RESULTING IN BRUISING ON THE ARM. THE MONITOR WAS REMOVED FROM SERVICE FOR REPAIR. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTION WAS REPORTED; THEREFORE, GOOD FAITH EFFORTS ARE BEING PERFORMED.

  Patient problems: Bruise/Contusion

  MAUDE report 21698032 ↗
• DeathMar 13, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THE USER HAD DIFFICULTY DIFFERENTIATING BETWEEN THE MATERNAL HEART RATE (MHR) AND FETAL HEART RATE (FHR) AND THE BABY WAS STILLBORN. THE 37 WEEK MOTHER PRESENTED TO THE LABOR WARD IN SEVERE ABDOMINAL PAIN WITH A BASE MHR OF 160 BPM. A DOPPLER WAS PERFORMED TO DETERMINE FETAL LIFE PRIOR TO CONNECTING THE MOTHER TO FETAL MONITOR. THE STAFF HAD DIFFICULTY DETERMINING WHICH RATE WAS THE MHR AND FHR, WHICH COINCIDENCE ALARMS BEING GENERATED BY THE MONITOR. THE BABY WAS STILLBORN; HOWEVER, THE FETAL MOVEMENT PROFILE (FMP) WAS STILL PRESENT. OVERALL, THE STAFF WAS CONFUSED AS TO FUNCTIONALITY OF THE MONITOR AND REQUESTED ASSISTANCE FOR EDUCATION AND EXPLANATION OF THE BEHAVIOR. ADDITIONAL INFORMATION RECEIVED INDICATED THE CAUSE OF DEATH WAS NOT KNOWN AS NO AUTOPSY WAS PERFORMED. THE FHR ALARMS WERE SOUNDING FROM THE BEGINNING OF THE CASE ONWARD BUT THE MOTHER WAS NOT CONNECTED TO SPO2 OR HR MONITORING DURING THE BIRTH. THE BABY WAS BORN VIA C-SECTION AND THE MIDWIVES WERE UNSURE WHETHER CONFUSION OVER THE ALARMS CONTRIBUTED TO THE OUTCOME. IT WAS ALSO INDICATED THERE WAS NO DEVICE FAULT. FURTHER INFORMATION RECEIVED INDICATED THE FHR AND MHR WERE TOO CLOSE, WITH THE MHR B

  Patient problems: Insufficient Information

  MAUDE report 21596907 ↗
• MalfunctionFeb 5, 2025No Audible Alarm; No Audible Alarm

  PHILIPS RECEIVED A COMPLAINT ON THE AVALON FM30 FETAL MONITOR INDICATING THAT A SPEAKER MALFUNCTION ERROR WAS DISPLAYED. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21313085 ↗
• MalfunctionJan 13, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  THE CUSTOMER REPORTED THAT THE SCREEN IS FROZEN, NEED TO CHECK TOCOCARDIOGRAPH. IT IS UNKNOWN IF THE DEVICE WAS IN CLINICAL USE AT TIME OF EVENT, NO ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21138724 ↗
• MalfunctionDec 3, 2024Loose or Intermittent Connection; Imprecise or Erratic Results; Loose or Intermittent Connection; Imprecise or Erratic Results

  THE CUSTOMER REPORTED THE FETAL MONITORING IS LOSING TRANSDUCER SIGNAL APPROXIMATELY EVERY TEN SECONDS AND WHEN IT CAME BACK THE HEART RATE WAS HIGH AND THEN WOULD DROP. THE USER SWAPPED THE US TRANSDUCERS AS THE SIGNAL WAS NOT PICKING UP; HOWEVER, EVEN THOUGH THE US TRANSDUCER WAS DOCKED, THE FM30 WAS STILL PICKING IT UP AND HAD NOT REMOVED IT FROM SCREEN. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT. NO ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20834605 ↗
• MalfunctionNov 25, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE FETAL HEART RATE (FHR) KEPT DROPPING OUT EVERY 10 SECONDS OR SO. WHEN IT CAME BACK, THE HEART RATE WAS HIGH AND THEN IT WOULD DROP. THE DEVICE WAS IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20772784 ↗
• MalfunctionNov 21, 2024Incorrect Measurement; High Test Results; Incorrect Measurement; High Test Results

  IT WAS REPORTED VIA A USER REPORT THAT THE MONITOR'S NON-STRESS TEST (NST) PRODUCED REPORTS THAT ARE INACCURATE. THE DEVICE INACCURACIES WERE AS DESCRIBED AS FOLLOWS: NST CRITERIA MET REPORTS ARE OUTSIDE THE GUIDELINES AND DO NOT MEET ALL ALGORITHM CRITERIA, PRODUCES REPORTS OVER THE CUT OFF PERCENTAGE OF SIGNAL LOSS, REPETITIVE DECELERATIONS MET, AND REPORTS NOT REPRESENTATIVE OF VISUAL RECORDING. BASED ON THE LIMITED INFORMATION RECEIVED, THERE WAS NO INDICATION THE REPORTED ISSUES CAUSED OR CONTRIBUTED TO ANY PATIENT HARM. AS THE INFORMATION PROVIDED DID NOT PROVIDE SPECIFICS OR ANY PATIENT IMPACT, GOOD FAITH EFFORTS ARE BEING PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20746908 ↗
• MalfunctionNov 21, 2024Incorrect Measurement; High Test Results; Incorrect Measurement; High Test Results

  IT WAS REPORTED VIA A USER REPORT THAT THE MONITOR'S NON-STRESS TEST (NST) PRODUCED REPORTS THAT ARE INACCURATE. THE DEVICE INACCURACIES WERE AS DESCRIBED AS FOLLOWS: NST CRITERIA MET REPORTS ARE OUTSIDE THE GUIDELINES AND DO NOT MEET ALL ALGORITHM CRITERIA, PRODUCES REPORTS OVER THE CUT OFF PERCENTAGE OF SIGNAL LOSS, REPETITIVE DECELERATIONS MET, AND REPORTS NOT REPRESENTATIVE OF VISUAL RECORDING. BASED ON THE LIMITED INFORMATION RECEIVED, THERE WAS NO INDICATION THE REPORTED ISSUES CAUSED OR CONTRIBUTED TO ANY PATIENT HARM. AS THE INFORMATION PROVIDED DID NOT PROVIDE SPECIFICS OR ANY PATIENT IMPACT, GOOD FAITH EFFORTS ARE BEING PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20746904 ↗
• MalfunctionNov 21, 2024Incorrect Measurement; High Test Results; Incorrect Measurement; High Test Results

  IT WAS REPORTED VIA A USER REPORT THAT THE MONITOR'S NON-STRESS TEST (NST) PRODUCED REPORTS THAT ARE INACCURATE. THE DEVICE INACCURACIES WERE AS DESCRIBED AS FOLLOWS: NST CRITERIA MET REPORTS ARE OUTSIDE THE GUIDELINES AND DO NOT MEET ALL ALGORITHM CRITERIA, PRODUCES REPORTS OVER THE CUT OFF PERCENTAGE OF SIGNAL LOSS, REPETITIVE DECELERATIONS MET, AND REPORTS NOT REPRESENTATIVE OF VISUAL RECORDING. BASED ON THE LIMITED INFORMATION RECEIVED, THERE WAS NO INDICATION THE REPORTED ISSUES CAUSED OR CONTRIBUTED TO ANY PATIENT HARM. AS THE INFORMATION PROVIDED DID NOT PROVIDE SPECIFICS OR ANY PATIENT IMPACT, GOOD FAITH EFFORTS ARE BEING PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20745734 ↗
• MalfunctionNov 21, 2024High Test Results; High Test Results

  IT WAS REPORTED VIA A USER REPORT THAT THE MONITOR'S NON-STRESS TEST (NST) PRODUCED REPORTS THAT ARE INACCURATE. THE DEVICE INACCURACIES WERE AS DESCRIBED AS FOLLOWS: NST CRITERIA MET REPORTS ARE OUTSIDE THE GUIDELINES AND DO NOT MEET ALL ALGORITHM CRITERIA, PRODUCES REPORTS OVER THE CUT OFF PERCENTAGE OF SIGNAL LOSS, REPETITIVE DECELERATIONS MET, AND REPORTS NOT REPRESENTATIVE OF VISUAL RECORDING. BASED ON THE LIMITED INFORMATION RECEIVED, THERE WAS NO INDICATION THE REPORTED ISSUES CAUSED OR CONTRIBUTED TO ANY PATIENT HARM. AS THE INFORMATION PROVIDED DID NOT PROVIDE SPECIFICS OR ANY PATIENT IMPACT, GOOD FAITH EFFORTS ARE BEING PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20745405 ↗
• MalfunctionNov 21, 2024Incorrect Measurement; High Test Results; Incorrect Measurement; High Test Results

  IT WAS REPORTED VIA A USER REPORT THAT THE MONITOR'S NON-STRESS TEST (NST) PRODUCED REPORTS THAT ARE INACCURATE. THE DEVICE INACCURACIES WERE AS DESCRIBED AS FOLLOWS: NST CRITERIA MET REPORTS ARE OUTSIDE THE GUIDELINES AND DO NOT MEET ALL ALGORITHM CRITERIA, PRODUCES REPORTS OVER THE CUT OFF PERCENTAGE OF SIGNAL LOSS, REPETITIVE DECELERATIONS MET, AND REPORTS NOT REPRESENTATIVE OF VISUAL RECORDING. BASED ON THE LIMITED INFORMATION RECEIVED, THERE WAS NO INDICATION THE REPORTED ISSUES CAUSED OR CONTRIBUTED TO ANY PATIENT HARM. AS THE INFORMATION PROVIDED DID NOT PROVIDE SPECIFICS OR ANY PATIENT IMPACT, GOOD FAITH EFFORTS ARE BEING PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20745251 ↗