PTV 19250-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00845873000005), received between Nov 27, 2018 and Mar 19, 2022 — classified as 1 death, 9 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (21 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2022Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED NOT HOLDING POSITIVE END-EXPIRATORY PRESSURE ON THE ENVE 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 13827329 ↗
• MalfunctionOct 16, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED FAILURE TO DISPLAY FRACTION OF INSPIRED OXYGEN ON THE ENVE 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 12643805 ↗
• DeathOct 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE DEVICE MALFUNCTIONED DURING USE ON A PATIENT ON THE ENVE VENTILATOR. THE CUSTOMER REPORTED PATIENT CODED THEN LATER ON EXPIRED WHILE CONNECTED TO THE DEVICE.

  Patient problems: Cardiac Arrest

  MAUDE report 12643802 ↗
• MalfunctionApr 28, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT THE ENVE VENTILATOR EXPERIENCED NOT WORKING PROPERLY WHILE ON PATIENT. AS OF THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT HARM WITH THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11740017 ↗
• MalfunctionJan 18, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT ENVE VENTILATOR TOUCH SCREEN IS TORN. AS OF THIS TIME, THERE IS NO INFORMATION ABOUT PATIENT INVOLVEMENT ASSOCIATED IN THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11183799 ↗
• MalfunctionDec 18, 2020Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT ENVE VENTILATOR HAVE INTERNAL LEAK. AS OF THIS TIME, THERE IS NO INFORMATION ABOUT PATIENT INVOLVEMENT ASSOCIATED IN THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11042194 ↗
• MalfunctionDec 17, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE ENVE VENTILATOR IS HAVING BLANK SCREEN. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11033815 ↗
• MalfunctionNov 16, 2020Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED ENVE UNIT IS DELIVERING HIGH VOLUMES. AS OF THIS TIME, THERE IS NO INFORMATION ABOUT PATIENT INVOLVEMENT ASSOCIATED IN THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10848930 ↗
• MalfunctionSep 11, 2020Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT THE SCROLL KNOB IS DEFECTIVE ON ENVE VENTILATOR. THE CUSTOMER CLAIMED WHEN THEY TRY TO CHANGE THE TIDAL VOLUMES THE VOLUMES ARE ALL OVER THE PLACE AND IS NOT LINEAR. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: Insufficient Information

  MAUDE report 10525735 ↗
• MalfunctionSep 4, 2020Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL WHEN TURNED ON THE SAFETY VALVE HIGH PRESSURE RELIEF, THE DEVICE WILL NOT DELIVER A BREATH ISSUE ON THE ENVE VENTILATOR. AS OF THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Information

  MAUDE report 10497437 ↗
• InjurySep 2, 2020Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE ENVE VENTILATOR FAILED ON A PATIENT. THEY TOOK IT OFF THE PATIENT AND POWER IT UP AGAIN AND THE CIRCUIT TEST FAILED. THE VENTILATOR WAS REMOVED FROM THE PATIENT AND THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10485778 ↗
• MalfunctionAug 21, 2020Tidal Volume Fluctuations; Tidal Volume Fluctuations

  THE CUSTOMER REPORTED THAT THE ENVE WAS NOT SHOWING VOLUME DELIVERY BUT THE PATIENT HAD WAVE FORMS AND CHEST RISE. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10437971 ↗
• MalfunctionApr 21, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE CUSTOMER REPORTED THAT THE ENVE VENTILATOR DISPLAY SCREEN IS NOT RESPONSIVE. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9982464 ↗
• MalfunctionFeb 3, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED TO VYAIRE THAT THE ENVE VENTILATOR EXPERIENCED SCREEN ISSUES. THE SCREEN IS SHOWING WAVY LINES THROUGHOUT THE DISPLAY. AT THIS TIME, IT IS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Information

  MAUDE report 9662252 ↗
• MalfunctionDec 23, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED TO VYAIRE THAT THE ENVE VENTILATOR EXPRESSED A BLANK SCREEN. AT THIS TIME, IT IS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED INCIDENT.

  Patient problems: No Information

  MAUDE report 9513604 ↗
• InjuryAug 27, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE THAT THE ENVE VENTILATOR WENT VENTILATOR INOPERABLE (INOP) WHILE CONNECTED TO A PATIENT. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8937433 ↗
• MalfunctionAug 6, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE THAT THE ENVE VENTILATOR WAS NOT DELIVERING ANY TIDAL VOLUME. AT THIS TIME, IT IS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Information

  MAUDE report 8865838 ↗
• MalfunctionJun 15, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VENTILATOR WAS ALARMING HW FAULT 20, THERE WAS NO REPORT OF ANY PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8702283 ↗
• InjuryMay 29, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE THAT THE ENVE VENTILATOR STOPPED VENTILATING WHILE CONNECTED TO A PATIENT. THE PATIENT WAS REMOVED FROM THE DEVICE AND PLACED ON ANOTHER VENTILATOR. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8650365 ↗
• InjuryMay 6, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE VIA AN FDA MEDWATCH THAT THE ENVE VENTILATOR AUTO -CYCLED WHILE CONNECTED TO A PATIENT. THE ENVE VENTILATOR STARTED TO TRIGGER NON-PATIENT INITIATED BREATHS CAUSING THE PATIENTS RESPIRATORY RATE TO INCREASE INTO THE 40'S AND THE TIDAL VOLUMES TO DECREASE INTO 100 MLS. . THE PROBLEM CONTINUED TO WHERE THE PATIENT HAD TO BE SEDATED, REMOVED FROM THE ENVE VENTILATOR, AND PLACED ON AN AVEA UNIT. THE CUSTOMER CONFIRMED THAT THE REPORTED ISSUE WAS RESOLVED ONCE THE PATIENT WAS PLACED ON ANOTHER UNIT. NO PATIENT HARM NOTED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8581947 ↗
• MalfunctionApr 18, 2019Overheating of Device; Overheating of Device

  IT WAS REPORTED TO VYAIRE THAT THE ENVE VENTILATOR HAD SMOKE COMING OUT OF THE UNIT WHILE CONNECTED TO A PATIENT. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8529264 ↗
• InjuryApr 18, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE VIA A MEDWATCH THAT THE ENVE VENTILATOR STOPPED VENTILATING WHILE CONNECTED TO A PATIENT. THE PATIENT'S SATURATION IMMEDIATELY DROPPED TO 85%. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PROVIDED POSITIVE AIRWAY PRESSURE VIA A BAG MASK VALVE. THE CUSTOMER CONFIRMED THAT THERE WAS NO FURTHER HARM TO THE PATIENT.

  Patient problems: Low Oxygen Saturation

  MAUDE report 8529232 ↗
• InjuryMar 7, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE THAT THE ENVE VENTILATOR STOPPED VENTILATING WHILE CONNECTED TO A PATIENT. THE PATIENT WAS IMMEDIATELY REMOVED AND PROVIDED POSITIVE PRESSURE VENTILATION VIA MANUAL RESUSCITATOR AND MOVED TO ANOTHER VENTILATOR. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8398758 ↗
• MalfunctionFeb 5, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE TOUCHSCREEN WAS FROZEN AND WILL NOT RESPOND. THERE WAS NO REPORT OF ANY PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8306834 ↗
• InjuryFeb 5, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE THAT THE ENVE VENTILATOR SHUT DOWN WHILE CONNECTED TO A PATIENT. THE CUSTOMER STATED THAT THERE IS NO INFORMATION REGARDING PATIENT HARM.

  Patient problems: No Information

  MAUDE report 8306816 ↗