Avalon Fetal Monitor FM50 Avalon FM50 Fetal MonitorRecalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 00884838000438), received between Dec 20, 2017 and Sep 29, 2026 — classified as 9 deaths, 7 injuries, 35 malfunctions.

The most frequently reported specific device problem is “No Audible Prompt/Feedback” (17 reports).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026No Audible Prompt/Feedback

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931989 ↗
• MalfunctionAug 12, 2026Imprecise or Erratic Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50220397 ↗
• MalfunctionApr 23, 2026Incorrect Measurement

  IT WAS REPORTED THAT THE UNIT READING PULSE AUX WHEN THERE IS NO PULSE AUX CONNECTED. IT IS UNKNOWN IF THE DEVICE WAS 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 24973180 ↗
• MalfunctionApr 20, 2026Incorrect, Inadequate or Imprecise Result or Readings; Imprecise or Erratic Results

  IT WAS REPORTED THAT THE AVALON FM50 FETAL MONITOR IS SHOWING A PULSE READING WHEN THERE IS NO PULSE CONNECTED. THE DEVICE WAS 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 24927529 ↗
• MalfunctionMar 26, 2026Incorrect Measurement

  PHILIPS RECEIVED A COMPLAINT ON AN AVALON FM50 FETAL MONITOR INDICATING THAT THE NON INVASIVE BLOOD PRESSURE PUMP (NIBP) WAS NOT PROVIDING ACCURATE MEASUREMENTS AND THE FM50 INTERMITTENTLY DISPLAYS INCORRECT NON INVASIVE BLOOD PRESSURE PUMP (NIBP) READINGS. 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 24700902 ↗
• MalfunctionFeb 4, 2026Incorrect Measurement

  PHILIPS RECEIVED A COMPLAINT ON AN AVALON FM50 FETAL MONITOR INDICATING THAT IN ROOM 5 THE FETAL HEARTRATE WAS MIMICKING THE MATERNAL HEARTRATE. 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 24256712 ↗
• MalfunctionFeb 4, 2026Incorrect Measurement

  PHILIPS RECEIVED A COMPLAINT ON AN AVALON FM50 FETAL MONITOR INDICATING THAT IN ROOM 5 THE FETAL HEARTRATE WAS MIMICKING THE MATERNAL HEARTRATE. 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 24256710 ↗
• DeathSep 5, 2025Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THE TRACINGS GENERATED VIA THE WIRELESS TRANSDUCER INTERMITTENTLY DROPPED OUT WHILE FETAL DECELERATIONS WERE OCCURRING, WHICH RESULTED IN THE PATIENT BEING TRANSPORTED TO ANOTHER HOSPITAL; HOWEVER, THE CUSTOMER INDICATED THEY DID NOT BELIEVE THE MONITOR ISSUE CONTRIBUTED TO THE PATIENT CONDITION. THE STAFF CHANGED TO WIRELESS MONITORING DUE TO THIS ISSUE AND INDICATED THIS LABOR AND DELIVERY ROOM IS THE ONLY ROOM EXPERIENCING THIS ISSUE. IT WAS ALSO NOTED THE HOSPITAL USES GE CENTRICITY FOR CENTRAL MONITORING. BASED ON THIS INFORMATION, THE FETUS EXHIBITED DECELERATIONS WHILE THERE WERE SIGNAL DROPOUTS, WHICH THE CUSTOMER DOES NOT BELIEVE WAS DUE TO THE DROPOUTS; HOWEVER, THE TYPE OF REPORTED COMPLAINT WAS MARKED AS DEATH.

  Patient problems: Insufficient Information

  MAUDE report 22978131 ↗
• MalfunctionJul 22, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  IT WAS REPORTED THE DEVICE IS DOUBLE COUNTING HEART RATE AND NOT IDENTIFYING PATIENTS CORRECTLY. 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 22568657 ↗
• DeathJul 1, 2025Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THE STAFF ATTEMPTED TO CONNECT ULTRASOUND AND TOCO TRANSDUCERS TO THE MOTHER BUT COULD NOT GET THE TRANSDUCERS TO CONNECT. THE MOTHER, WHO WAS PREGNANT WITH TWINS, WAS IN THE LABOR AND DELIVERY ROOM AND ALL DEVICES WERE WORKING CORRECTLY. THE MOTHER WAS TRANSPORTED TO THE OR TO DELIVER THE FIRST BABY BUT THEN TRANSPORTED BACK TO L&D TO DELIVER THE SECOND BABY, WHO WAS IN A GOOD POSITION FOR A NATURAL BIRTH. WHEN ATTEMPTING TO CONNECT THE MOTHER TO WIRELESS TRANSDUCERS, THE TRANSDUCERS WOULD NOT CONNECT TO THE FETAL MONITOR. AFTER TROUBLESHOOTING FOR 8 MINUTES, A WIRED TRANSDUCER WAS OBTAINED; HOWEVER, AROUND MINUTE 10, THE BABY HAD ALREADY BEEN BORN. THIRTY MINUTES LATER, THE SECOND BABY PASSED AWAY DUE TO NATURAL CAUSES; HOWEVER, THE CAUSE OF DEATH REMAINS UNKNOWN. THE MONITOR WAS VISUALLY INSPECTED BY THE FIELD SERVICE ENGINEER, REVEALING NO ANOMALIES. THE ULTRASOUND AND TOCO TRANSDUCERS WERE LATCHED IMMEDIATELY UPON DOCKING AND THE ENGINEER WAS UNABLE TO REPLICATE THE COMPLAINT.

  Patient problems: Insufficient Information

  MAUDE report 22373789 ↗
• DeathJun 17, 2025Unable to Obtain Readings; Unable to Obtain Readings

  PHILIPS RECEIVED A COMPLAINT ON AN AVALON FM50 FETAL MONITOR INDICATING THAT THE FETAL HEART RATE (FHR) WAS NOT ABLE TO BE MEASURED AND THE BABY PASSED AWAY AFTER BIRTH. THE MOTHER AT 37 WEEKS PLUS 4 DAYS GESTATION PRESENTED WITH AN INTERMITTENT CATEGORY 2 TRACING (NEITHER REASSURING NOR NON-REASSURING TRACE) WITH IMPROVEMENT OVER 24 HOURS WITH POSITION CHANGES. THE PATIENT THEN HAD A QUICK CHANGE TO A CATEGORY 3 TRACING (PROLONGED DECELERATIONS) AND WAS TRANSFERRED EMERGENTLY TO THE OR, WHERE THE FETAL HEART RATE IMPROVED SO A VACUUM-ASSISTED DELIVERY WAS ATTEMPTED, WHICH WAS UNSUCCESSFUL, AND THE MOTHER WAS RELUCTANT TO GO TO C-SECTION. DURING THESE ATTEMPTS THE FHR WAS LOST FOR MORE THAN 8 MINUTES SO AN EMERGENT C-SECTION WAS PERFORMED. THE BABY WAS CYANOTIC AND UNRESPONSIVE AND REQUIRED RESUSCITATION. EMERGENT INTUBATION AND TRANSFER TO NICU AND ACTIVE COOLING WAS ATTEMPTED. CARE WAS SUBSEQUENTLY WITHDRAWN AND DEATH WAS DUE TO SEVERE HYPOXIC-ISCHEMIC ENCEPHALOPATHY. THE MATERNAL HEART RATE (MHR) WAS MONITORED AT THE TIME, AND IT WAS THOUGHT BECAUSE THE MHR AND FHR WERE BEING PICKED UP INTERCHANGEABLY, THERE WAS A DELAY IN CARE, WHICH AFFECTED THE OUTCOME. BASED ON THIS INFORMAT

  Patient problems: Encephalopathy; Hypoxia in Utero

  MAUDE report 22230555 ↗
• DeathMar 31, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THE PATIENT WAS BORN WITH SEVERE ACIDOSIS AND CARED FOR IMMEDIATELY BUT PASSED AWAY AFTER 55 MINUTES. THE USER THOUGHT THE PROBLEM MAY HAVE BEEN THAT THE DEVICE SWITCHED THE FETAL AND MATERNAL PULSE ON THE PRINTED TRACE. THE DEVICE REMAINS IN USE. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTION WAS REPORTED; THEREFORE, GOOD FAITH EFFORTS ARE BEING PERFORMED.

  Patient problems: Respiratory Acidosis

  MAUDE report 21734289 ↗
• MalfunctionJun 5, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  PHILIPS RECEIVED A COMPLAINT ON THE AVALON FM50 FETAL MONITOR INDICATING THE SYSTEM WAS NOT PICKING UP ANY FETAL SOUND WHEN SCANNING. 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 19469730 ↗
• MalfunctionJun 4, 2024No Audible Alarm; No Audible Alarm

  THE CUSTOMER REPORTED THAT THERE WAS NO AUDIO, EVEN AFTER LOUDSPEAKER REPLACEMENT. 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 19461757 ↗
• DeathJun 3, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  PHILIPS RECEIVED A COMPLAINT ON THE AVALON FM50 FETAL MONITOR INDICATING THE SYSTEM SPO2 CABLE IS WORKING RESULTING IN A PATIENT'S DEATH. THE DEVICE WAS IN USE ON PATIENT AT TIME OF EVENT, THERE WAS AN ADVERSE EVENT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19446976 ↗
• MalfunctionApr 25, 2024No Audible Alarm; No Audible Alarm

  THE CUSTOMER REPORTED THE AVALON FM50 FETAL MONITOR IS NOT PRODUCING ANY AUDIO. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19180411 ↗
• MalfunctionNov 15, 2023No Audible Prompt/Feedback; No Audible Prompt/Feedback

  IT WAS REPORTED THE AVALON FM50 FETAL MONITOR DISPLAY A SPEAKER MALFUNCTION ERROR. PATIENT INVOLVEMENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18138165 ↗
• MalfunctionNov 3, 2023No Audible Alarm; No Audible Alarm

  THE CUSTOMER REPORTED A LOUDSPEAKER ERROR IS DISPLAYED. THE DEVICE WAS IN USE AT THE TIME OF THE EVENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18069987 ↗
• MalfunctionOct 27, 2023No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER REPORTED THAT NO SOUND WAS COMING FROM THE AVALON FM50 FETAL MONITOR DESPITE THE REPLACEMENT OF THE SPEAKER. THE DEVICE WAS NOT IN USE AT TIME OF EVENT, NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18022799 ↗
• MalfunctionAug 8, 2023No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER REPORTED A SPEAKER MALFUNCTION FROM THE DEVICE. THE DEVICE WAS NOT IN USE AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17481434 ↗
• MalfunctionJul 3, 2023Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED THAT THE SPO2 NUMBERS NOT CORRECT AND RELIABEL FROM THE DEVICE. THE DEVICE WAS IN USE AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17245762 ↗
• MalfunctionJun 12, 2023No Audible Prompt/Feedback; No Audible Prompt/Feedback

  IT WAS REPORTED THE DEVICE HAS A SPEAKER MALFUNCTION. IT IS UNKNOWN IF THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT, NO ADVERSE EVENT OR PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17107588 ↗
• MalfunctionMar 20, 2023Audible Prompt/Feedback Problem; Audible Prompt/Feedback Problem

  THE CUSTOMER REPORTED THAT THE USER IS GETTING A SPEAKER MALFUNCTION. THERE WAS NO REPORTED ADVERSE EVENT TO THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16577526 ↗
• InjuryDec 2, 2022Use of Device Problem; Use of Device Problem

  DURING A CUSTOMER SITE VISIT, THE CUSTOMER REPORTED THAT THEY WERE UNABLE TO ASSESS FETAL HEART STATUS WHILE A PATIENT WAS BEING MOVED TO THE OR DURING FETAL DISTRESS. THE PATIENT WAS SURGICALLY DELIVERED VIA CAESARIAN SECTION. THE SURGICAL DELIVERY WAS A SUCCESS, AND THERE WAS NO HARM TO THE BABY. THE REGISTERED NURSE (RN) STATED THAT HAD THE STAFF BEEN ABLE TO CONTINUE MONITORING THE FETAL HEART, A SURGICAL DELIVERY MAY HAVE BEEN AVOIDED. A PHILIPS CLINICAL SOLUTIONS IMPLEMENTATION CONSULTANT (CSIC) SPOKE TO THE CUSTOMER AT THE TIME OF THE SITE VISIT. THE RN STATED THAT AT THE TIME OF THE EVENT THE SITE WAS GETTING NEW FETAL MONITORS (FM50, REVISION L) TO REPLACE ALL CURRENTLY INSTALLED FETAL MONITORS (FM50, REVISION G). THE RN FURTHER STATED THAT DUE TO THE MONITORS IN THE OPERATING ROOM (OR) NOT BEING EXCHANGED WHEN THE LABOR & DELIVERY MONITORS WERE ALREADY EXCHANGED, THEY WERE UNABLE TO ASSESS FETAL HEART STATUS. THE CSIC WAS ABLE TO CONFIRM THAT THE OR FETAL MONITORS HAD ALREADY BEEN UPGRADED TO REVISION L AT THE TIME OF THE EVENT. THE CSIC STATES THAT THERE IS A DELAY OF APPROXIMATELY 10 SECONDS WHEN CONNECTING THE TOCO+MP WITH A FETAL SPIRAL ELECTRODE ATTACHED TO THE FETAL

  Patient problems: Insufficient Information

  MAUDE report 15905857 ↗
• InjuryOct 17, 2022Manufacturing, Packaging or Shipping Problem

  THE CUSTOMER REQUESTED DOCUMENTING CONCERNING (B)(4) OR SERVICE HISTORY OF A FCO BEING APPLIED TO THE DEVICE IN QUESTION. A PHILIPS PRODUCT SUPPORT ENGINEER (PSE) PROVIDED ANOTHER FCO (B)(4) IN WHICH THE SERIAL NUMBER WAS LISTED ON THE CAN APPLICATION LAYER (CAL). A PHILIPS REGIONAL SERVICE MANAGER (RSM) FOLLOWED UP WITH CUSTOMER, AND TOLD THEM PHILIPS WILL CONTINUE TO RESEARCH THE REQUEST AND THAT THE INITIAL FCO WAS FOR AN ADDENDUM TO THE INSTRUCTION FOR USE IFU. AT THE TIME OF THE FOLLOW-UP, THE CUSTOMER INDICATED THEY WANTED TO BE TRANSPARENT THAT THE REASON WHY THEY ARE ASKING FOR THE DOCUMENTATION WAS DUE TO PENDING LITIGATION. IT IS UNKNOWN IF THE DEVICE WAS IN CLINICAL USE. THE REPORT WAS MARKED AS PATIENT HARM. THE NATURE OF THE HARM WAS NOT PROVIDED AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15614909 ↗