Avalon TOCO+ Transducer (REF 989803143681)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00884838002715), received between Oct 13, 2021 and Dec 4, 2024 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2024Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THE READING OF THE AV-TOCO TOCO+ TRANSDUCER IS INCORRECT. THE DEVICE WAS NOT 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 20842716 ↗
• InjuryDec 14, 2022Failure to Transmit Record; Failure to Transmit Record

  THE CUSTOMER REPORTED THAT THE MATERNAL PULSE IS TEMPORARILY EVEN HOURLY NOT TRANSMITTED AND THERE WAS AN EMERGENCY C-SECTION IN LABOR ROOM 7. THE DEVICE WAS IN USE ON A PATIENT AND THERE WAS REPORT OF PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 15975531 ↗
• MalfunctionSep 2, 2022Incorrect Measurement; Incorrect Measurement

  THE SENSOR SIZZLES AND HAS DIFFICULTY STABILIZING. IT IS UNKNOWN IF THE DEVICE WAS IN USE AT THE TIME OF THE EVENT, NO ADVERSE EVENT TO PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15348045 ↗
• InjuryOct 13, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THREE (3) PATIENTS IN LABOR AND DELIVERY HAD EXPERIENCED BURNS FROM USING OUR PHILIPS FETAL MONITOR. THE BURN OCCURRED FORM THE SENSOR (TOKOS)(SP) PLACED ON THE PATIENT¿S BELLY.

  Patient problems: Skin Burning Sensation

  MAUDE report 12624739 ↗
• InjuryOct 13, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT (3) PATIENTS IN LABOR AND DELIVERY HAD EXPERIENCED BURNS FROM USING OUR PHILIPS FETAL MONITOR. THE BURN OCCURRED FORM THE SENSOR (TOKOS)(SP) PLACED ON THE PATIENT¿S BELLY. A

  Patient problems: Skin Burning Sensation

  MAUDE report 12624044 ↗