Avalon CL Toco+ MP Transducer Avalon Cableless Toco+ MP TransducerRecalls & reported problems
Philips Medizin Systeme Böblingen GmbH · Avalon Cableless Toco+ MP Transducer for use with Avalon CL Basestation 866074. Toco Transducer with Avalon Smart Pulse measurement and connector for maternal ECG, fetal ECG or IUP measurement. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00884838034235), received between Mar 4, 2020 and Sep 28, 2026 — classified as 5 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Incorrect Measurement” (5 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.
Reports received per month
Most reported problems
Device problems
- Incorrect Measurement5
- Insufficient Device Problem Information2
- Overheating of Device2
- Adverse Event Without Identified Device or Use Problem1
- Defective Alarm1
- Device Reprocessing Problem1
- Unintended Electrical Shock1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- Blister2
- Injury1
- Insufficient Information1
- Superficial (First Degree) Burn1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924051 ↗MalfunctionJul 21, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25886817 ↗MalfunctionJun 12, 2026Incorrect Measurement
PHILIPS RECEIVED A COMPLAINT ON THE AVALON CABLELESS TOCO+ MP TRANSDUCER INDICATING THAT THE DEVICE IS NOT READING CORRECTLY WHEN PRESSURE IS APPLIED. THE DEVICE WAS NOT IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25490956 ↗InjuryOct 21, 2025Device Reprocessing Problem; Device Reprocessing Problem
IT WAS REPORTED, THE TRANSDUCERS ARE CRUMBLING WHEN CLEANED WITH OXIVIR EXCEL WIPES. THIS REPORTED ISSUE IS OCCURRING AT SEVERAL CUSTOMER HOSPITAL SITES. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTION WAS.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23349560 ↗InjuryOct 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED BLISTERS WERE PRESENT ON THE PATIENT UNDER THE ULTRASOUND TRANSDUCER DURING USE. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTION WAS REPORTED.
Patient problems: Blister
MAUDE report 23312353 ↗MalfunctionOct 15, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED BLISTERS FORMED UNDER THE TRANSDUCER DURING USE. THE BLISTERING WAS RAISED, CLEAR, FLUID FILLED AND OCCURRED UNDER THE SMOOTH PART OF THE TRANSDUCER. THE TRANSDUCER WAS IN PLACE APPROXIMATELY 3-4 HOURS. THE PHYSICIAN WAS NOTIFIED BUT THE BLISTERING WAS NOT CLASSIFIED IN A BURN CATEGORY. THERE WAS NO TREATMENT PROVIDED, AND THE BURN WAS EXPECTED TO HEAL COMPLETELY. THE TRANSDUCER WAS MOVED TO ANOTHER AREA ON THE ABDOMEN, BUT IT WAS NOT NOTED BY THE USER IF THE TRANSDUCER WAS HOT TO THE TOUCH. THE SPECIFIC TRANSDUCER COULD NOT BE LOCATED FOR ANALYSIS.
Patient problems: Blister
MAUDE report 23299875 ↗MalfunctionDec 19, 2023Defective Alarm; Defective Alarm
PHILIPS RECEIVED A COMPLAINT ON THE AVCL-TOCO REPLACEMENT XDR ISM INDICATING THAT THE CL TRANSDUCER LED TURNS CYAN, WITH AN INTERMITTENT AUDIBLE ALARM. IT WAS REPORTED THAT THE AVALON CL BASE DID NOT DETECT THIS TRANSDUCER, AND THERE WAS NO INOP MESSAGE ON THE MONITOR TO STATE THE BATTERY ON THIS TRANSDUCER WAS EMPTY. 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 18355845 ↗InjuryOct 31, 2022Overheating of Device; Overheating of Device
DURING A PATIENT SCAN, THE UNIT OVERHEATED AND BURNED THE PATIENT. AS A RESULT THE PATIENT REQUIRED TREATMENT A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15704532 ↗InjuryOct 28, 2022Overheating of Device; Overheating of Device
THE CUSTOMER REPORTED THAT THE UNIT OVERHEATED AND BURNED THE PATIENT. THE PATIENT REQUIRED TREATMENT.
Patient problems: Superficial (First Degree) Burn
MAUDE report 15691176 ↗MalfunctionJun 21, 2022Unintended Electrical Shock; Unintended Electrical Shock
THE CUSTOMER REPORTED THAT THE UNIT NEEDS TO BE EVALUATED FOR SAFETY INCIDENT. PATIENT CLAIMED TO HAVE BEEN SHOCKED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14759773 ↗MalfunctionJun 17, 2022Incorrect Measurement; Incorrect Measurement
THE CUSTOMER REPORTED THAT THE DEVICE GIVES IRREGULAR AND UNSTABLE PRESSURE VALUES. IT IS UNKNOWN IF THE DEVICE WAS IN USE AT TIME OF EVENT AND THERE WAS NO ADVERSE EVENT TO THE PATIENT/USER WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14738518 ↗MalfunctionSep 23, 2021Incorrect Measurement; Incorrect Measurement
THE CUSTOMER STATED THAT A MOTHER (YOUNG WOMAN) WAS MONITORED AND HER INDUCTION OF LABOR. MOTHER HAS A BABY WITH AUDIBLE ECTOPIC HEART BEATS. BABY WAS BEING EXTERNALLY MONITORED. ON VAGINAL EXAMINATION A FETAL SCALP ELECTRODE WAS PLACED TO PROVIDE SUPERIOR MONITORING GIVEN THE CLINICAL CONDITION OF THE BABY / ALLOW GREATER UNINHIBITED MATERNAL MOVEMENT. LARGE DARK LINES WERE SEEN ON THE MONITOR. PATIENT WAS IN ACTIVE LABOUR WHICH CONTINUED. DUE TO NOT BEING ABLE TO MONITOR FHR ACCURATELY A CODE RED - TRANSFER TO OR FOR +/- CESAREAN SECTION, WAS CALLED. PATIENT TAKEN TO THEATRE FOR DELIVERY. THERE WAS NO HARM TO MOTHER OR BABY BUT A CODE RED INTERVENTION WAS REQUIRED. PATIENT WAS TAKEN TO THEATRE BUT DID NOT REQUIRE A CESAREAN SECTION, FORCEPS DELIVERY, AND MOTHER AND BABY WELL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12520512 ↗InjuryMar 4, 2020Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED THAT AFTER CHILDBIRTH, THERE WAS A LARGE WOUND FOUND ON MOTHER'S BELLY. IT IS DIFFICULT TO DETERMINE IF IT WAS CAUSED BY PRESSURE, HEAT OR HYPERSENSITIVITY. THERE WAS A CONTINUOUS REGISTRATION FOR 17 HOURS, AND IT IS UNCLEAR IF THE TRANSDUCER WAS REPOSITIONED. THE WOUND WAS DISCOVERED IN CONNECTION WITH THE POST CARE A FEW HOURS AFTER BIRTH.
Patient problems: Injury
MAUDE report 9784993 ↗
Other MONITOR, UTERINE CONTRACTION, EXTERNAL (FOR USE IN CLINIC) devices
- Avalon TOCO MP TransducerPhilips Medizin Systeme Böblingen GmbH · MONITOR, UTERINE CONTRACTION, EXTERNAL (FOR USE IN CLINIC)8 reports
- Avalon TOCO+ TransducerPhilips Medizin Systeme Böblingen GmbH · MONITOR, UTERINE CONTRACTION, EXTERNAL (FOR USE IN CLINIC)5 reports
- Avalon Fetal & Maternal Patch Avalon CL Fetal & Maternal PatchPhilips Medical Systems Hsg · Monitor, uterine contraction, external (for use in clinic)3 reports
- Avalon CL Fetal & Maternal PodPhilips Medizin Systeme Böblingen GmbH · Monitor, uterine contraction, external (for use in clinic)1 report
- Avalon Toco MP TransducerPhilips Medizin Systeme Böblingen GmbH · Monitor, uterine contraction, external (for use in clinic)1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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