Bird Blender 03920ARecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10846446002355), received between Nov 19, 2019 and May 23, 2024 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (12 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 16, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryMay 23, 2024High Readings; High Readings

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE BLENDER WAS CONSTANTLY DELIVERING 100% FIO2. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19382864 ↗
• MalfunctionJan 23, 2024Failure to Align; Failure to Align

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE BIRD¿ LOW FLOW AIR/O2BLENDER HAS A PROBLEM WITH THE KNOB (HAS NOT LIMIT) AND NEEDS OVERHAUL. AS OF THIS TIME, THERE IS NO INFORMATION ABOUT PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18567719 ↗
• MalfunctionOct 27, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE MICBLNDR HAS AN ISSUE WITH FIO2 (FRACTION OF INSPIRED OXYGEN) BEING INACCURATE. CUSTOMER DID NOT SPECIFY HOW INACCURATE OR AT WHAT SET POINTS. FURTHERMORE, THERE WAS NO INFORMATION REGARDING PATIENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18026382 ↗
• MalfunctionMar 10, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE KNOB OF THE BLENDER HAS DAMAGED DURING PATIENT USE. FURTHERMORE, THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16524942 ↗
• MalfunctionFeb 27, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE CONTROL KNOB OF THE BLENDER WAS BROKEN PRIOR TO PATIENT USE FROM WHERE IT SHOULD BE IN RELATION TO THE SET THE FIO2 (FRACTION OF INSPIRED OXYGEN).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16448963 ↗
• MalfunctionJan 11, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL PROBLEM WITH BLENDER WHERE IT IS NOT PULLING O2 UNTIL IT IS SET OVER 25%. FURTHERMORE, THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16135687 ↗
• MalfunctionDec 14, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT 'LOW SUPPLY' ALARM DOES NOT COME ON AND SLIDER ON THE AIR SIDE WAS NOT MOVING ON THE MICROBLENDER. THERE IS NO INFORMATION OF PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT AS OF THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15979444 ↗
• MalfunctionOct 12, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE MICROBLENDER IS LEAKING MORE THAN USUAL FROM THE BLEED FLOW. AT THIS TIME THERE WAS NO INFORMATION OF PATIENT INVOLVEMENT REPORTED FROM THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15589241 ↗
• MalfunctionDec 16, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL BLENDER IS READING HIGH AND OUT OF SPEC AT A DIAL SETTING OF 21%. THE REPORTER CONFIRMED THAT THERE IS NO PATIENT INVOLVEMENT ASSOCIATED ON THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13023359 ↗
• MalfunctionDec 16, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL BLENDER IS READING HIGH AND OUT OF SPEC AT A DIAL SETTING OF 21%. THE REPORTER CONFIRMED THAT THERE IS NO PATIENT INVOLVEMENT ASSOCIATED ON THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13023350 ↗
• MalfunctionDec 16, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE LOW FLOW MICROBLENDER VENTILATOR IS READING HIGH AND OUT OF SPECIFICATION AT A DIAL SETTING OF 21%. FURTHERMORE, THERE WAS NO PATIENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13023279 ↗
• MalfunctionDec 15, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE LOW FLOW MICROBLENDER VENTILATOR IS READING HIGH AND OUT OF SPECIFICATION AT A DIAL SETTING OF 21%. AS OF THIS TIME THERE IS NO INFORMATION ABOUT PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13014770 ↗
• MalfunctionDec 15, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE LOW FLOW MICROBLENDER VENTILATOR IS READING HIGH AND OUT OF SPECIFICATION AT A DIAL SETTING OF 21%. AS OF THIS TIME THERE IS NO INFORMATION ABOUT PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13014743 ↗
• MalfunctionMar 3, 2021Contamination; Contamination

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE LOW FLOW MICROBLENDER HAS OXYGEN CONTAMINATION OF MEDICAL AIR. AS OF THIS TIME THERE IS NO INFORMATION ABOUT PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11405317 ↗
• MalfunctionApr 1, 2020Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT THE 3920 LOW FLOW MICRO BLENDER SERIES FIO2 IS OUT OF SPECS. AS OF THIS TIME THERE IS NO INFORMATION ABOUT PATIENT INVOLVEMENT IN THIS REPORTED EVENT.

  Patient problems: No Information

  MAUDE report 9909035 ↗
• MalfunctionJan 17, 2020Output above Specifications; Output above Specifications

  THE CUSTOMER REPORTED THE BIRD BLENDER WAS SET TO TWENTY-ONE PERCENT (21%) OF FRACTION OF INSPIRED OXYGEN (FIO2). THE CUSTOMER REPORTED UPON FURTHER INVESTIGATION, THE DEVICE WAS GIVING OFF 87.5% FIO2.

  Patient problems: No Information

  MAUDE report 9602610 ↗
• MalfunctionNov 19, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE THAT THE MICROBLENDER FAILED TO ALARM WHEN ONE GAS WAS LOST. THE CUSTOMER ADVISED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9343467 ↗