Vital Signs™ ADU320X4DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10190752121522), received between Mar 29, 2023 and Mar 29, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 29, 2023Deflation Problem; Deflation Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT MANY OF THEIR ADU320X4D ANES CIRCUIT, ADULT, 108 IN EXP, 3L BAG HAVE BEEN COMING IN WITHOUT ANY AIR IN THE MASK OR WITH VERY LITTLE AIR. THEY ARE ALL DEFLATED. THIS CAN CAUSE PROBLEMS IN THE CASE OF EMERGENCIES. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM/INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16639545 ↗
• MalfunctionMar 29, 2023Deflation Problem; Deflation Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT MANY OF THEIR ADU320X4D - ANES CIRCUIT, ADULT, 108 IN EXP, 3L BAG HAVE BEEN COMING IN WITHOUT ANY AIR IN THE MASK OR WITH VERY LITTLE AIR. THEY ARE ALL DEFLATED. THIS CAN CAUSE PROBLEMS IN THE CASE OF EMERGENCIES. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM/INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16639536 ↗