Vyaire V-178603Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04250892904719), received between Jul 7, 2021 and Sep 18, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2024Battery Problem; Battery Problem

  THE CUSTOMER REPORTED THAT THE KEYBOARD OF THE VYNTUS ONE LAPTOP FROM DELL IS PUFFED OUT, WHICH POSSIBLY COULD BE THE RESULT OF A SWOLLEN BATTERY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20243843 ↗
• InjuryOct 1, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT A PATIENT UNDERWENT ROUTINE LUNG FUNCTION TESTS ON THE VYNTUS ONE AS PER USUAL PROTOCOL. HOWEVER, WHEN THE PATIENT TOOK AN INSPIRATORY EFFORT DURING THE TRANSFER FACTOR TEST, THE FLOW HEAD DETACHED AND CONSEQUENTLY CAUSING ONE OF HIS TEETH TO BREAK/LOOSEN. THE PATIENT'S HAND WAS ALSO INJURED.

  Patient problems: Tooth Fracture

  MAUDE report 12564993 ↗
• MalfunctionJul 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED TO VYAIRE MEDICAL THAT THERE IS AN INJURY CAUSED BY USS FALLING OUT OF THE FPV E-DEMAND. IT WAS CONFIRMED THAT IT WAS A MINOR INJURY ON THE SKIN OF THE HAND OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12131118 ↗