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Vital Signs™ 6861Recalls & reported problems

Vyaire Medical, Inc. · Vital Signs™ Extra Large Mask with Adjustable Air Cushion Size 6 · Class 1

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10190752147379), received between Jun 28, 2021 and Jun 28, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Inflation 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Inflation Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 28, 2021Inflation Problem; Inflation Problem

    THE PRODUCT IS AVAILABLE TO BE RETURNED FOR INVESTIGATION. PICTURES ARE ALSO ATTACHED. THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE 6861- VITAL SIGNS® EXTRA LARGE FACE MASK WITH ADJUSTABLE AIR CUSHION SIZE 6X -LARGE ADULT FACE MASK, DEFLATED WHILE CONNECTED TO A PATIENT. THE CUSTOMER CONFIRMED THAT THERE WAS NO HARM AND THERE WAS NO INTERVENTION NEEDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12081210 ↗

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Sources and updates

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