Vital Signs™ AMY520X4F (UDI 10190752123014)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10190752123014), received between Feb 28, 2020 and Sep 11, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Blocked Connection” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2025Partial Blockage; No Device Output; Failure to Deliver; Blocked Connection; No Flow; Partial Blockage; No Device Output; Failure to Deliver; Blocked Connection; No Flow

  IT WAS REPORTED THAT DURING PROCEDURE THE HME PORT WAS OCCLUDED. WHILE NO HARM OR INJURY WAS REPORTED TO THE PATIENT IF THIS WERE TO REOCCUR THE PATIENT COULD BECOME HYPOXIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23032572 ↗
• InjuryJun 21, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED TO VYAIRE MEDICAL THAT A PATIENT EXPERIENCED AN ADVERSE EVENT WHILE CONNECTED TO SKU: AMY520X4F, PRODUCT: VITAL SIGNS ADULT ANESTHESIA BREATHING CIRCUIT. THE PATIENT BEGAN HIS EMERGENCE FROM THE GENERAL ANESTHETIC IN A VERY ROBUST MANNER; ALMOST IMMEDIATELY, HIS OXYGEN SATURATION, BLOOD PRESSURE, AND HEART RATE BEGAN TO FALL RAPIDLY. THE ANESTHESIA EMERGENCY BUTTON WAS ACTIVATED, AND SEVERAL FACULTIES ARRIVED QUICKLY. WHILE PROCEDURES WERE BEING DONE, HOSPITAL STAFF DISCONNECTED THE ET TUBE FROM THE VENTILATOR, AND A SUCTION CATHETER WAS PLACED IN THE ET TUBE WITHOUT OBSTRUCTION. AT THIS POINT, WHEN A SECOND RESIDENT WENT TO REATTACH THE VENTILATOR TUBING TO THE ET TUBE, SHE NOTICED A FOREIGN OBJECT LODGED IN THE ELBOW CONNECTER OF THE VENTILATOR TUBING. THE ELBOW WAS IMMEDIATELY REMOVED, THE VENTILATOR TUBING WAS REATTACHED TO THE ET TUBE, AND I WAS ABLE TO VENTILATE THE PATIENT WITHOUT PROBLEMS EFFICIENTLY. HE HAD DEVELOPED A PULSELESS ELECTRICAL ACTIVITY EARLY ON AS HIS SATURATIONS FELL AND HIS BLOOD PRESSURE DROPPED. HE UNDERWENT AGGRESSIVE CPR BY THE OR NURSING. HE HAD A RETURN OF SPONTANEOUS CONTRACTIONS (ROSC) ALMOST IMMEDIATELY AFTER THE PHYSICIAN WAS ABLE T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14760701 ↗
• InjuryJun 15, 2022Defective Device; Defective Device

  IT WAS REPORTED TO VYAIRE MEDICAL THAT A PATIENT EXPERIENCED AN ADVERSE EVENT WHILE CONNECTED TO SKU: AMY520X4F PRODUCT: VITAL SIGNS ADULT ANESTHESIA BREATHING CIRCUIT. THE CUSTOMER SAID THAT THE PATIENT SUSTAINED TETANUS UPON COMPLETING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). THE ATTENDING ANESTHESIOLOGIST PAGED HIS TEAM TO NOTIFY THEM OF THE "WAKING UP" PATIENT. THE PATIENT REMAINED ON THE VENTILATOR, WAITING TO RETURN TO SPONTANEOUS VENTILATION. THE PATIENT SUDDENLY WOKE UP, AND THE TEAM IMMEDIATELY REMOVED THE PATIENT FROM THE VENTILATOR AND PROVIDED POSITIVE PRESSURE VENTILATION VIA A BAG-MASK VALVE. MINIMAL ETCO2 WAS NOTED WITH SMALL TIDAL VOLUMES. THE CLINICIANS STATED THAT THEY COULD NOT MAINTAIN ANY PRESSURE FROM THE BAG. THE CLINICIANS CHECKED FOR A CIRCUIT LEAK, BUT NONE WERE FOUND, AND THE PATIENT WAS PLACED BACK ON THE VENTILATOR. THE PATIENT'S SATURATION BEGAN TO DROP, AND THEIR HEART RATE DECREASED TO THE '30S. THE STAFF DECIDED TO BEGIN CHEST COMPRESSIONS AND GIVE THE PATIENT THE NECESSARY DRUGS TO RAISE ALL VITAL SIGNS. THE PHYSICIAN NOTICED THAT THE CIRCUIT HME FILTER WAS STICKING OUT OF THE END OF THE REINFORCED ENDOTRACHEAL TUBE. THE HME FILTER WAS WITHDRA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14706731 ↗
• MalfunctionFeb 28, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE CUSTOMER REPORTED THAT THE VITAL SIGNS® ADULT ANESTHESIA BREATHING CIRCUIT IS LEAKING WHILE CONNECTED HOWEVER THE CUSTOMER CONFIRMED THAT NO PATIENT HARM WAS ASSOCIATED ON THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9771963 ↗