3100B HFOV 770155 (UDI 10846446003543)Recalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 10846446003543), received between Nov 21, 2018 and Jun 18, 2024 — classified as 1 death, 8 injuries, 52 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (37 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 25 most recent of 61 reports, in the reporter's own words as published by the FDA.

• InjuryJun 18, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE DEVICE WORKED FINE UNTIL THE 14-15TH HOUR WHEN THEY HEARD A LOUD HIGH-PITCHED WHISTLING SOUND AND THE PISTON STOPPED (A050402 GAS/AIR LEAK). NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19562654 ↗
• MalfunctionFeb 1, 2024Increase in Pressure; Increase in Pressure

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 3100B WHEN DEVICE IS POWERED ON, THE MAP INCREMENTALLY INCREASED TO MAX (~60CMH2O) WITHOUT ANY INTERVENTION. THE CUSTOMER CONFIRMED THAT THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18622970 ↗
• MalfunctionJan 18, 2024Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED TO VYAIRE MEDICAL THAT TEH 3100B VENTILATOR MAP (MEAN AIRWAY PRESSURE) WONT ADJUST BELOW 4CMH2O DURING PRESSURE XDCR (TRANSDUCER) ADJUSTMENTS IN THE 2K. 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 18536879 ↗
• MalfunctionJan 2, 2024Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED TO VYAIRE MEDICAL THAT UNSTABLE FREQUENCY OCCURRED ON THE 3100 B VENTILATOR. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18432523 ↗
• MalfunctionDec 19, 2023Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED TO VYAIRE MEDICAL THAT NO MEAN AIRWAY PRESSURE AND DELTA P OCCURRED ON THE 3100 B VENTILATOR. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18361130 ↗
• MalfunctionAug 31, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE 3100B VENTILATOR PISTON POSITION WAS NOT DISPLAYING. THE AMPLITUDE, INSPIRATORY TIME (NORMALLY 33), AND FREQUENCY (NORMALLY 3-15) WERE ALL DISPLAYING ABNORMAL VALUES OF 52. 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 17666697 ↗
• MalfunctionJul 18, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL AN EXCESSIVE CONDENSATION IN ALL LINES OF THE 3100B VENTILATOR. IT WAS ALSO STATED THAT THE UNIT WAS FAILING TO HOLD A PRESS. THE ISSUE HAPPENED DURING PATIENT USE. AT THIS TIME, THE CUSTOMER HAS NOT PROVIDED ANY INFORMATION REGARDING PATIENT HARM OR INJURY ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17346937 ↗
• MalfunctionJun 29, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 3100B VENTILATOR HAD THE BATTERY LOW LED LIT. 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 17232809 ↗
• MalfunctionJun 19, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT ISSUES WITH PEAK TO PEAKS OCCURRED ON THE 3100 B VENTILATOR. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17153354 ↗
• MalfunctionApr 11, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 3100B VENTILATOR CAN ONLY GET 35CM ON THE MAP (MEAN AIRWAY 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 16718705 ↗
• MalfunctionFeb 16, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT UNIT IS NOT PRESSURIZING ON THE 3100 B DEVICE. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16390111 ↗
• MalfunctionNov 22, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 3100B VENTILATOR MAP (MEAN AIRWAY PRESSURE) IS READING NEGATIVE NUMBERS AND FLUCTUATING BETWEEN -0.7 AND- 0.4, THERE IS NO CIRCUIT ON THE UNIT. THE DRIVER SEEMS TO BE PUSHED OUT, WITH NO AIR PLUGGED IN. 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 15849671 ↗
• MalfunctionOct 4, 2022Pressure Problem; Pressure Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE UNIT WILL NOT PRESSUURIZE ON THE 3100 B VENTILATOR. 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 15541048 ↗
• MalfunctionSep 23, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 3100B VENTILATOR MAP (MEAN AIRWAY PRESSURE) FLUCTUATES AT 10CMH2O. 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 15472965 ↗
• MalfunctionAug 26, 2022Temperature Problem; Temperature Problem

  IT WAS REPORTED TO VYAIRE MEDICAL DEVICE OVERHEATED AND STOPPED OSCILLATING DURING USE ON A PATIENT ON THE 3100 B VENTILATOR. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15307478 ↗
• MalfunctionAug 9, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 3100B VENTILATOR OVERHEATED AND STOPPED OSCILLATING WHILE ON A PATIENT. AT THIS TIME, THE CUSTOMER HAS NOT PROVIDED ANY INFORMATION REGARDING PATIENT INJURY OR HARM ASSOCIATED WITH THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15193994 ↗
• MalfunctionJul 28, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 3100B VENTILATOR KEEPS DUMPING MAP (MEAN AIRWAY PRESSURE) WHILE ON A PATIENT. AS OF THIS TIME, THERE IS NO INFORMATION ABOUT PATIENT HARM ASSOCIATED WITH THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15126996 ↗
• InjuryJul 21, 2022Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE 3100B VENTILATOR APPEARED TO PASS THE PERFORMANCE TEST, BUT IT FAILED ON A PATIENT, AND CARBON DIOXIDE (CO2) CONTINUED TO RISE. THE ISSUE OCCURRED DURING PATIENT-USE AND THE DEVICE WAS REPLACED WITH ANOTHER VENTILATOR. AT THIS TIME, THERE WAS NO INFORMATION FOR PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15077607 ↗
• MalfunctionJul 19, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 3100B VENTILATOR HAS PRESSURE HIGHER THAN 21CM AND WON'T PASS CIRCUIT CALIBRATION. AT THIS TIME THERE WAS NO INFORMATION OF PATIENT INVOLVEMENT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15061477 ↗
• DeathMar 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE DELTA P ON THE 3100 B VENTILATOR WAS FLUCTUATING BETWEEN 90CMH2O AND 120CMH2O WHEN SET TO 110CMH2O. THE PATIENT WAS IN STABLE CONDITION THE WHOLE TIME BUT EXPIRED THE NEXT DAY. THE CUSTOMER DID NOT THINK IT WAS DUE TO THE VENTILATOR.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13831593 ↗
• MalfunctionFeb 2, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 3100 B VENTILATOR AMPLITUDE SETTING WAS ONLY READING 104-105 CM. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13425529 ↗
• MalfunctionJan 12, 2022Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE 3100B HAS DEFECTIVE PRESSURE TRANSDUCER. 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 13238867 ↗
• MalfunctionDec 30, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT 3100B VENTILATOR IS PRESSURIZING BUT WILL NOT OSCILLATE. FURTHERMORE, THERE WAS NO PATIENT INVOLVED IN THE SAID EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13119150 ↗
• MalfunctionDec 30, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT 3100B VENTILATOR HAS A LEAKING ISSUE THROUGH THE ADJUSTMENT SCREW. FURTHERMORE, THERE WAS NO PATIENT INVOLVED IN THE SAID EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13118825 ↗
• MalfunctionDec 15, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE 3100B VENTILATOR UNIT HAS MAP READING 110. 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 13014817 ↗