Jaeger V-175423Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04250892905204), received between Dec 16, 2019 and Dec 20, 2019 — classified as 2 malfunctions.

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

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 20, 2019Device Emits Odor; Fumes or Vapors; Device Emits Odor; Fumes or Vapors

  THE CUSTOMER REPORTED THE FOLLOWING: DEFECTIVE MASTERSCREEN CONTROL UNIT WITH A BURNING SMELL. THE CUSTOMER REPORTED SUPPOSEDLY THERE WAS A FIRE AND THE CONTROL UNIT WAS DROPPED, BECAME HOT AND MELTED. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9504170 ↗
• MalfunctionDec 16, 2019Fumes or Vapors; Defective Device; Fumes or Vapors; Defective Device

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL A BURNT OR CHARRED SMELL COMING FROM THE SYSTEM BOX OF THE MASTERSCREEN BODY/DIFF. THE CUSTOMER WAS UNABLE TO MEASURE GAS CALIBRATION. THE CUSTOMER REPORTED THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9476380 ↗