Vital Signs™ 2464AAO-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 10190752188181), received between Sep 29, 2022 and Sep 11, 2024 — classified as 9 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (29 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. How this data works · Data updated Oct 13, 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 11, 2024Material Too Rigid or Stiff; Material Integrity Problem; Material Too Rigid or Stiff; Material Integrity Problem

  CANNOT CONSISTENTLY ATTACH THE CABLE PORTION TO THE SET TO THE ATTACHMENT PAD. IT DOES NOT ALWAYS SNAP INTO PLACE. THE ADHESIVE ALSO DOES NOT STICK WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20195915 ↗
• MalfunctionFeb 22, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED TO VYAIRE MEDICAL THAT DURING PATIENT USE THE LEG ATTACHMENT PAD FOR COROMETRICS FETAL SCALP ELECTRODE CABLE NEEDS TO BE TAPED TO STAY CONNECTED. FURTHERMORE, NO HARM WAS DONE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18758707 ↗
• MalfunctionFeb 13, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED TO VYAIRE MEDICAL THAT DURING PATIENT USE THE LEG ATTACHMENT PAD FOR COROMETRICS FETAL SCALP ELECTRODE CABLE NEEDS TO BE TAPED TO STAY CONNECTED. FURTHERMORE, NO HARM WAS DONE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18695139 ↗
• MalfunctionFeb 13, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED TO VYAIRE MEDICAL THAT DURING PATIENT USE THE LEG ATTACHMENT PAD FOR COROMETRICS FETAL SCALP ELECTRODE CABLE NEEDS TO BE TAPED TO STAY CONNECTED. FURTHERMORE, NO HARM WAS DONE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18695133 ↗
• InjuryFeb 3, 2024Disconnection; Disconnection

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THEY ARE CURRENTLY TAPING DOWN THE 2464AAO-20 - LEG ATTACHMENT PAD FOR COROMETRICS FETAL SCALP ELECTRODE CABLE TO THE LEG PLATE SO THAT IT WILL STAY ATTACHED. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18637036 ↗
• MalfunctionJan 14, 2024Disconnection; Disconnection

  THE CUSTOMER REPORTED THAT THE LEG ATTACHMENT PAD WOULD NOT STAY CONNECTED TO THE CABLE. THE NURSE WILL PUSH DOWN AND PINCH IT, AND IT WILL TRANSMIT PROPERLY, BUT WHEN THEY LET GO, IT CREATES AN ARTIFACT, AND THE FETAL HEART RATE CANNOT BE TRACED. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18509773 ↗
• MalfunctionOct 12, 2023Connection Problem; Connection Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THEY ARE ATTEMPTING TO PLACE FETAL SPIRAL ELECTRODE FOR COROMETRICS ON A TRIAL OF LABOR AFTER CESAREAN DELIVERY (TOLAC) PATIENT WHO WAS LABORING NATURALLY AND THE PRODUCT WOULD NOT STAY SNAPPED INTO PLACE NOR WOULD IT STICK TO THE PATIENT'S LEG. FURTHERMORE, THE CUSTOMER CONFIRMED NO HARM WAS DONE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17927773 ↗
• MalfunctionSep 26, 2023Connection Problem; Connection Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE LEG ATTACHMENT PAD FOR COROMETRICS FETAL SCALP ELECTRODE CABLE WILL NOT STAY ON THE PATIENT. THIS PREVENTS SAFE MONITORING. ADDITIONALLY, THERE IS NO INFORMATION REGARDING PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17822543 ↗
• MalfunctionSep 26, 2023Connection Problem; Connection Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE LEG ATTACHMENT PAD FOR COROMETRICS FETAL SCALP ELECTRODE CABLE WILL NOT STICK TO THE SKIN. FURTHERMORE, THE THERE IS NO INFORMATION REGARDING PATIENT HARM WAS DONE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17822540 ↗
• MalfunctionSep 26, 2023Connection Problem; Connection Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE LEG ATTACHMENT PAD FOR COROMETRICS FETAL SCALP ELECTRODE CABLE DOES NOT STAY SECURELY AND DOES NOT MAKE GOOD CONTACT DURING PATIENT USE. THE DEVICE IS EASILY DETACHED, WHICH RESULTS IN INACCURATE FETAL HEART RATE READING. ADDITIONALLY, THERE IS NO INFORMATION REGARDING PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17822536 ↗
• MalfunctionSep 25, 2023Connection Problem; Connection Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE LEG ATTACHMENT PAD FOR COROMETRICS FETAL SCALP ELECTRODE CABLE DOES NOT STAY ATTACHED TO FETAL SCALP ELECTRODE CORD. ADDITIONALLY, THERE IS NO INFORMATION REGARDING PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17807914 ↗
• MalfunctionSep 25, 2023Connection Problem; Connection Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE LEG ATTACHMENT PAD FOR COROMETRICS FETAL SCALP ELECTRODE CABLE DOES NOT FIT INTO CONNECTION TO ALLOW READING AND ALSO DOESN'T STICK ON LEG DURING PATIENT USE. ADDITIONALLY, THERE IS NO INFORMATION REGARDING PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17807906 ↗
• MalfunctionSep 25, 2023Connection Problem; Connection Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE LEG ATTACHMENT PAD FOR COROMETRICS FETAL SCALP ELECTRODE CABLE WON'T CONNECT OR STICK ON TOP AND ALSO WON'T SNAP IN. ADDITIONALLY, THERE IS NO INFORMATION REGARDING PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17807861 ↗
• MalfunctionAug 31, 2023Connection Problem; Connection Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE LEG ATTACHMENT PAD FOR COROMETRICS FETAL SCALP ELECTRODE CABLE SNAP PULLING OFF PAD AND THE PAD NOT STICKING DURING PATIENT USE. FURTHERMORE, THE CUSTOMER CONFIRMED NO HARM WAS DONE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17667575 ↗
• MalfunctionAug 28, 2023Connection Problem; Connection Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 2464AAO-20 LEG ATTACHMENT PAD FOR COROMETRICS FETAL SCALP ELECTRODE CABLE WAS NOT VERY STICKY AND COMES OFF DURING AN ASSESSMENT WITH THE PATIENT. FURTHER INVESTIGATIONS WITH THE USERS, IT HAS REVEALED IT IS NOT ONLY AN ADHESIVE ISSUE, BUT ALSO CONNECTION BETWEEN THE PAD AND THE SPIRAL ELECTRODE. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17638669 ↗
• MalfunctionAug 28, 2023Connection Problem; Connection Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 2464AAO-20 LEG ATTACHMENT PAD FOR COROMETRICS FETAL SCALP ELECTRODE CABLE WAS NOT VERY STICKY AND COMES OFF DURING AN ASSESSMENT WITH THE PATIENT. FURTHER INVESTIGATIONS WITH THE USERS, IT HAS REVEALED IT IS NOT ONLY AN ADHESIVE ISSUE, BUT ALSO CONNECTION BETWEEN THE PAD AND THE SPIRAL ELECTRODE. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17638653 ↗
• MalfunctionAug 13, 2023Connection Problem; Connection Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE METAL DEVICE ON LEG ATTACHMENT PAD FOR COROMETRICS FETAL SCALP ELECTRODE CABLE DOES NOT HAVE ENOUGH OF A DEFINED LIP TO KEEP THE CONNECTION INTACT. FURTHERMORE, THERE IS NO INFORMATION FOR PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17538067 ↗
• MalfunctionJul 11, 2023Connection Problem; Connection Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 2464AAO-20 LEG ATTACHMENT PAD FOR COROMETRICS FETAL SCALP ELECTRODE CABLE WAS FAULTY AND THE FETAL HEART RATE DOES NOT TRACE APPROPRIATELY WHICH CAN PUT THE PATIENT/NEWBORN AT RISK. AT THIS TIME, THE CUSTOMER HAS NOT PROVIDED ANY INFORMATION REGARDING PATIENT HARM OR INJURY ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17302790 ↗
• MalfunctionJun 2, 2023Connection Problem; Connection Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE LEG ATTACHMENT PAD FOR COROMETRICS FETAL SCALP ELECTRODE CABLE ARE NOT CLICKING WITH THE VITAL SIGNS¿ FETAL SPIRAL ELECTRODE CABLE FOR COROMETRICS, ROUND CONNECTOR, 2.4 M. THE DEVICE IS EASILY DETACHED AND COULD CAUSE A MISS READ PUTTING THE PATIENTS AT RISK. THE PATIENTS CANNOT BE MONITORED CORRECTLY AT THIS TIME, THE CUSTOMER HAS NOT PROVIDED ANY INFORMATION REGARDING PATIENT HARM OR INJURY ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17052046 ↗
• MalfunctionJun 2, 2023Connection Problem; Connection Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE LEG ATTACHMENT PAD FOR COROMETRICS FETAL SCALP ELECTRODE CABLE ARE NOT CLICKING WITH THE VITAL SIGNS¿ FETAL SPIRAL ELECTRODE CABLE FOR COROMETRICS, ROUND CONNECTOR, 2.4 M. THE DEVICE IS EASILY DETACHED AND COULD CAUSE A MISS READ PUTTING THE PATIENTS AT RISK. THE PATIENTS CANNOT BE MONITORED CORRECTLY. AT THIS TIME, THE CUSTOMER HAS NOT PROVIDED ANY INFORMATION REGARDING PATIENT HARM OR INJURY ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17052037 ↗
• MalfunctionJun 2, 2023Connection Problem; Connection Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE LEG ATTACHMENT PAD FOR COROMETRICS FETAL SCALP ELECTRODE CABLE ARE NOT CLICKING WITH THE VITAL SIGNS¿ FETAL SPIRAL ELECTRODE CABLE FOR COROMETRICS, ROUND CONNECTOR, 2.4 M. THE DEVICE IS EASILY DETACHED AND COULD CAUSE A MISS READ PUTTING THE PATIENTS AT RISK. THE PATIENTS CANNOT BE MONITORED CORRECTLY. AT THIS TIME, THE CUSTOMER HAS NOT PROVIDED ANY INFORMATION REGARDING PATIENT HARM OR INJURY ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17051898 ↗
• MalfunctionJun 2, 2023Connection Problem; Connection Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE LEG ATTACHMENT PAD FOR COROMETRICS FETAL SCALP ELECTRODE CABLE ARE NOT CLICKING WITH THE VITAL SIGNS¿ FETAL SPIRAL ELECTRODE CABLE FOR COROMETRICS, ROUND CONNECTOR, 2.4 M. THE DEVICE IS EASILY DETACHED AND COULD CAUSE A MISS READ PUTTING THE PATIENTS AT RISK.THE PATIENTS CANNOT BE MONITORED CORRECTLY.AT THIS TIME, THE CUSTOMER HAS NOT PROVIDED ANY INFORMATION REGARDING PATIENT HARM OR INJURY ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17051875 ↗
• MalfunctionJun 1, 2023Connection Problem; Connection Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE LEG ATTACHMENT PAD FOR COROMETRICS FETAL SCALP ELECTRODE CABLE IS NOT CLICKING WITH THE CABLE 1590AAO DURING PATIENT USE. THE DEVICE IS EASILY DETACHED, WHICH RESULTS IN A LOSS OF FETAL HEART RATE SIGNAL. THE CUSTOMER HAD TO TAPE THE CABLE TO THE ATTACH PAD PRIOR TO ADHERING IT TO THE PATIENTS LEG AND REINFORCING WITH MORE TAPE. FURTHERMORE, THE CUSTOMER CONFIRMED NO HARM WAS DONE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17040098 ↗
• MalfunctionMay 9, 2023Connection Problem; Connection Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT DURING PATIENT USE THE CUSTOMER NOTICED THAT THE LED PAD ATTACHMENT THEY HAD IS NOT PERFECTLY ROUND AND HAD BEEN BENT NEAR THE BASE OF THE BUTTON. THESE HAVE NOT BEEN ABLE TO CONNECT SECURELY TO GET A GOOD READING. FURTHERMORE, THE CUSTOMER CONFIRMED NO HARM WAS DONE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16899066 ↗
• MalfunctionApr 28, 2023Connection Problem; Connection Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE LEG ATTACHMENT PAD FOR COROMETRICS FETAL SCALP ELECTRODE CABLE DOES NOT FIT TO THE CONNECTING CORD. MULTIPLE LEG PADS HAVE TO BE USED ON A SINGLE PATIENT. THE ISSUE HAPPENED DURING PATIENT USE AND THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16835006 ↗