Blender 03800ARecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10846446002348), received between Dec 20, 2018 and Nov 9, 2023 — classified as 1 death, 3 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (10 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 9, 2023Inaccurate Delivery; Inaccurate Delivery

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE MICRO BLENDER IS NOT SENDING OUT THE CORRECT O2 (OXYGEN) PERCENTAGE TO PATIENTS. THE CUSTOMER CONFIRMED THAT THERE IS NO PATIENT HARM ASSOCIATED WITH THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18102650 ↗
• MalfunctionOct 2, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED TO VYAIRE MEDICAL THAT BLENDER IS LEAKING FROM THE AUXILLARY PORT ON THE MICROBLENDER DEVICE. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17852933 ↗
• MalfunctionFeb 21, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE MICRO BLENDER NOT MEASURE THE DIFFERENCE IN THE 20 PSI (POUNDS PER SQUARE INCH) CORRECTLY. 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 16414762 ↗
• MalfunctionJan 30, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE FRONT KNOB ON THE MICROBLENDER WAS DAMAGED. THERE WAS NO PATIENT INVOLVED IN THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16268826 ↗
• DeathJun 25, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE MICROBLENDER WAS INCORRECTLY SET TO 21% FIO2 (FRACTION OF INSPIRED OXYGEN). THE PATIENT WAS IN CRITICAL DESATURATION WHILE USING THE OPTIFLOW THRIVE. THE PATIENT HAS EXPIRED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 14812456 ↗
• MalfunctionApr 6, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT WHEN THE MICROBLENDER IS RUNNING AT 50LPM OR ABOVE ON THE AUXILIARY PORT AND TRYING TO GET TO 100% TO CHECK THE TOLERANCE, THE BLENDER STARTS ALARMING. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14026629 ↗
• MalfunctionDec 15, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE HIGH FLOW MICROBLENDER VENTILATOR ALARMS WHEN AIR AND OXYGEN LINES ARE ON EQUAL PRESSURE. 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 13014793 ↗
• MalfunctionDec 4, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED FRACTION OF INSPIRED OXYGEN OUT OF SPECIFICATION ON THE MICROBLENDER. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12930356 ↗
• InjuryApr 28, 2021Mechanical Problem; Mechanical Problem

  .THE CUSTOMER REPORTED PATIENT WAS IN SEVERE RESPIRATORY DISTRESS WITH DESATURATION INTO THE 60S ON THE HIGH FLOW MICROBLENDER. THE CUSTOMER REPORTED THAT THE PATIENT WAS TRANSFERRED TO A VENTILATOR AND IMPROVED SIGNIFICANTLY.

  Patient problems: Low Oxygen Saturation

  MAUDE report 11740062 ↗
• MalfunctionMar 3, 2021Contamination; Contamination

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE HIGH 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 11405255 ↗
• MalfunctionFeb 2, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT THE MICROBLENDER COULD NOT GET THE ALARM SOUND AT ALL. THE CUSTOMER SET THE CONTROL KNOB AT 60% AND FLOW FROM 2LPM TO WIDE OPEN JUST CONNECTING THE AIR THEN CONNECTING JUST THE OXYGEN THERE IS NO ALARM. 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 11269972 ↗
• MalfunctionJan 19, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE MICROBLENDER VENTILATOR ALARMED WHEN THE FIO2 IS GREATER THAN 70%. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11197862 ↗
• MalfunctionOct 9, 2020Device Alarm System; Device Alarm System

  THE CUSTOMER REPORTED THAT THE 3800 HIGH FLOW MICROBLENDER SERIES EXPERIENCED STUCK BYPASS ALARM AND WOULD NOT STOP ALARMING. THE CUSTOMER CONFIRMED THAT HERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10657838 ↗
• InjuryJun 19, 2019Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED WHILE SETTING UP AN INFANT ON THE HIGH FREQUENCY OSCILLATORY VENTILATOR (HFOV), THE THERAPIST NOTED THAT PATIENT WAS DESALTING WHILE ON ONE-HUNDRED PERCENT (100%) OXYGEN. AFTER TROUBLESHOOTING AND ADJUSTMENTS, THE THERAPIST TRACED THE O2 HOSE AND DETERMINED THAT THE O2 BLENDER HOSE WAS MIS-CONNECTED ON THE HFOV. THE BLENDER DID NOT GIVE NOTICE OF THE MIS-CONNECTION BY ALARMING. THE CUSTOMER REPORTED THE BLENDER WAS REPLACED AND O2 SATURATION READINGS ROSE ON INFANT. INFANT ABLE TO MAINTAIN O2 SAT OF 88 WITH FIO2 SET AT 23%-28%. BLENDER REMOVED AND SENT TO BIOMEDICAL (BME) FOR INSPECTION. BME INSPECTION OF BLENDER NOTED THAT THE ALARM "WHISTLE" CAP WAS DEFECTIVELY NOT ALLOWING BLENDER TO ALARM WHEN JUST ONE GAS WAS CONNECTED. BME REPLACED ALARM CAP AND BLENDER WAS ABLE TO ALARM ON AIR OR O2 HOSE DISCONNECT.

  Patient problems: Low Oxygen Saturation

  MAUDE report 8713829 ↗
• InjuryJun 12, 2019Output Problem; Output Problem

  THE CUSTOMER REPORTED A SUSPECTED SERIOUS INJURY INVOLVING A BIRD 3800A MICROBLENDER THAT WAS DETECTED AT THE USER FACILITY. ON (B)(6) 2019 IT WAS DISCOVERED THAT THE DIAL WAS SET AT TWENTY-ONE PERCENT (21%) OXYGEN (O2). HOWEVER, WAS FOUND DELIVERING NINETY-SIX PERCENT (96%) O2 WHEN ANALYZED. THE ISSUE OCCURRED ON A PREMATURE NEONATE. ON (B)(6) 2019, THE NEONATE UNDERWENT AN EYE EXAMINATION WHICH SHOWED BILATERAL RETINOPATHY OF PREMATURITY. THE CUSTOMER REPORTED THE INVOLVED MACHINE WAS IMMEDIATELY TAKEN OUT OF SERVICE ON (B)(6) 2019 AND WAS CONFIRMED TO BE ADMINISTERING THE INCORRECT OXYGEN BLEND.

  Patient problems: Retinal Injury

  MAUDE report 8691250 ↗
• MalfunctionFeb 27, 2019Misassembly During Maintenance/Repair; Misassembly During Maintenance/Repair

  THE CUSTOMER REPORTED WHILE USING THE HIGH FLOW MICROBLENDER; THE FRACTION OF INSPIRED OXYGEN (FIO2) IS OUT OF SPECIFICATIONS AT 30%. THE CUSTOMER REPORTED MESSING WITH THE KNOB, ADJUSTING THE SEAT, AND NOW IT IS ALL OUT OF SPECIFICATIONS. THE CUSTOMER REPORTED TO NOT BEING TRAINED TO PERFORM OVERHAUL OF THE DEVICE AND WANTED TO RETURN THE DEVICE TO VYAIRE'S FACTORY SERVICE FOR EVALUATION/REPAIR. THE CUSTOMER REPORTED THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8376007 ↗
• MalfunctionDec 20, 2018Device Alarm System; Device Alarm System

  THE CUSTOMER REPORTED WHILE USING THE HIGH FLOW MICROBLENDER; THE LOSS OF OXYGEN/AIR HIGH PRESSURE ALARM FAILS. THE CUSTOMER PERFORMED TROUBLESHOOTING, BUT THE ISSUE WENT UNRESOLVED. THE CUSTOMER REPORTED THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8185250 ↗
• MalfunctionDec 20, 2018Output Problem; Output Problem

  THE CUSTOMER REPORTED WHILE USING THE HIGH FLOW MICROBLENDER; THE OXYGEN DIAL IS INACCURATE. THE CUSTOMER PERFORMED TROUBLESHOOTING, BUT THE ISSUE WENT UNRESOLVED. THE CUSTOMER REPORTED THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8185211 ↗
• MalfunctionDec 20, 2018Device Alarm System; Device Alarm System

  THE CUSTOMER REPORTED WHILE USING THE HIGH FLOW MICROBLENDER; THE LOSS OF OXYGEN/AIR HIGH PRESSURE ALARM FAILS. THE CUSTOMER PERFORMED TROUBLESHOOTING, BUT THE ISSUE WENT UNRESOLVED. THE CUSTOMER REPORTED THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8185200 ↗
• MalfunctionDec 20, 2018Output Problem; Output Problem

  THE CUSTOMER REPORTED WHILE USING THE HIGH FLOW MICROBLENDER; THE LOSS OF OXYGEN/AIR HIGH PRESSURE ALARM FAILS. THE INVOLVEMENT ASSOCIATED WITH THE EVENT. CUSTOMER PERFORMED TROUBLESHOOTING, BUT THE ISSUE WENT UNRESOLVED. THE CUSTOMER REPORTED THERE IS NO PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8184981 ↗
• MalfunctionDec 20, 2018Device Alarm System; Device Alarm System

  THE CUSTOMER REPORTED WHILE USING THE HIGH FLOW MICROBLENDER; THE LOSS OF OXYGEN/AIR HIGH PRESSURE ALARM FAILS. THE CUSTOMER PERFORMED TROUBLESHOOTING, BUT THE ISSUE WENT UNRESOLVED. THE CUSTOMER REPORTED THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8184967 ↗
• MalfunctionDec 20, 2018Device Alarm System; Device Alarm System

  THE CUSTOMER REPORTED WHILE USING THE HIGH FLOW MICROBLENDER; THE LOSS OF OXYGEN/AIR HIGH PRESSURE ALARM FAILS. THE CUSTOMER PERFORMED TROUBLESHOOTING, BUT THE ISSUE WENT UNRESOLVED. THE CUSTOMER REPORTED THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8184944 ↗
• MalfunctionDec 20, 2018Device Alarm System; Device Alarm System

  THE CUSTOMER REPORTED WHILE USING THE HIGH FLOW MICROBLENDER; THE LOSS OF OXYGEN/AIR HIGH PRESSURE ALARM FAILS. THE CUSTOMER PERFORMED TROUBLESHOOTING, BUT THE ISSUE WENT UNRESOLVED. THE CUSTOMER REPORTED THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8184928 ↗