Vital Signs 7000AAORecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10885403248962), received between Feb 26, 2020 and Nov 17, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Unable to Obtain Readings” (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 18, 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.

• MalfunctionNov 17, 2022Unable to Obtain Readings; Unable to Obtain Readings

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE ELECTRODES, FETAL SCALP (FSE), 50/CASE WOULD NOT TRACE THE FETAL HEART RATE. THERE IS NO INFORMATION ON THE PATIENT'S CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15820598 ↗
• MalfunctionAug 5, 2021Defective Device; Defective Device

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE 7000AAO VITAL SIGNS¿ FETAL SPIRAL ELECTRODE FOR COROMETRICS IS DEFECTIVE. THE PHYSICIAN NOTED AND SHE HAD TO PULL THIS THROUGH THE UTERUS ATTACHED TO THE FETAL SCALP AND WAS UNABLE TO REMOVE IT PRIOR TO THE SURGERY. DURING LABOR, SHE HAD PLACED A SECOND ONE, AND REFERRED TO THE ONE SHE COULD NOT REMOVE AS THE ""EXTRA FSE"". AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT. THERE IS NO INFORMATION REGARDING REMEDIAL ACTION TAKEN BY THE HEALTHCARE FACILITY HOWEVER, IT WAS REMOVED AFTER DELIVERY THOUGH IT IS UNCLEAR AS TO WHO REMOVED IT BASED ON THE DOCUMENTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12283482 ↗
• MalfunctionJun 23, 2021Entrapment of Device

  THE PHYSICIAN NOTED AND SHE HAD TO PULL THIS THROUGH THE UTERUS ATTACHED TO THE FETAL SCALP AND WAS UNABLE TO REMOVE IT PRIOR TO THE SURGERY. DURING LABOR SHE HAD PLACED A SECOND ONE, AND REFERRED TO THE ONE SHE COULD NOT REMOVE AS THE "EXTRA FSE." IT IS UNCLEAR WHO REMOVED IT AFTER DELIVERY BASED ON DOCUMENTATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12048885 ↗
• MalfunctionApr 3, 2020Unable to Obtain Readings; Unable to Obtain Readings

  THE CUSTOMER REPORTED THAT THE FETAL SPIRAL ELECTRODE FOR COROMETRICS DID NOT PICK UP FETAL HEART RATE WHEN APPLIED BY PHYSICIAN DURING LABOR AND DELIVERY. THERE WAS NO INDICATION OF PATIENT HARM OR MEDICAL INTERVENTION DURING INITIAL CONTACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9919480 ↗
• MalfunctionFeb 26, 2020Therapeutic or Diagnostic Output Failure

  ATTEMPTED TO USE FETAL SPIRAL ELECTRODE AND IT DID NOT WORK ACCURATELY. IT DID NOT PICK UP FETAL HEART RATE WHEN APPLIED BY PHYSICIAN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9753466 ↗