Vital Signs™ 6850Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10190752147461), received between Dec 13, 2021 and Dec 12, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Deflation 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 16, 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.

• MalfunctionDec 12, 2022Deflation Problem; Material Fragmentation; Deflation Problem; Material Fragmentation

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 6850 - MASK, ANES, FLEX, ADULT SIZE 5, TOP VLV WOULDN'T FILL UP WITH AIR AND LITTLE PIECES BROKE OFF INTO THE CHAMBER. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15958531 ↗
• MalfunctionJun 19, 2022Inflation Problem; Inflation Problem

  THE CUSTOMER REPORTED THAT THE 6850-VITAL SIGNS® ADULT FACE MASK WITH ADJUSTABLE AIR CUSHION SIZE 5 ARE NOT INFLATED WELL WHEN HE TRIES TO INFLATE MORE AIR AND IT'S NOT GIVING HIM A GOOD SEAL. THE CUSTOMER MENTIONED THAT THIS COULD BE A PROBLEM IF HE RUNS INTO A SITUATION VENTILATING A PATIENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14741330 ↗
• InjuryDec 13, 2021Human-Device Interface Problem; Human-Device Interface Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT DURING AN OPERATION, THE CUSTOMER HAD CIRCULAR DERMATITIS AT THE CONTACT AREA OF THE 6850 VITAL SIGNS® ADULT FACE MASK WITH ADJUSTABLE AIR CUSHION SIZE 5, AS AN INTERVENTION, THE PATIENT WILL HAVE A DERMATITIS CHECK UP.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 12983666 ↗