LTV 1150 VENTILATOR 18984-001 (UDI 10190752115644)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10190752115644), received between Jun 1, 2022 and Jun 23, 2025 — classified as 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2025Display Difficult to Read; Display Difficult to Read

  COMPLAINANT ALLEGED THAT THE LED LIGHTS ARE GOING OUT AND BLANKING OUT ON THE DEVICE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22310285 ↗
• MalfunctionApr 1, 2025Noise, Audible; Noise, Audible

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE WAS MAKING AN UNUSUAL NOISE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.

  Patient problems: Insufficient Information

  MAUDE report 21737621 ↗
• MalfunctionJun 19, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE DISPLAY HAD A FAULTY LED. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19571280 ↗
• InjuryJun 7, 2024Use of Incorrect Control/Treatment Settings; Inaccurate Flow Rate; Use of Incorrect Control/Treatment Settings; Inaccurate Flow Rate

  IT WAS REPORTED TO VYAIRE MEDICAL THE LTV VENTILATOR PRESENTED A LOW PRESSURE ALARM. THE PATIENT WENT INTO CARDIAC ARREST. CPR WAS INITIATED AND RETURN OF SPONTANEOUS CIRCULATION WAS ACHIEVED. THE PATIENT WAS SWITCHED OVER TO ANOTHER VENTILATOR. NO INJURY OR HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19488848 ↗
• InjuryApr 15, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VENTILATOR IS ON A PATIENT AND JUST STARTED BEEPING EVERY 20 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19105223 ↗
• MalfunctionNov 28, 2023Failure to Cycle; Failure to Cycle

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE LAP TOP VENTILATOR 1150 HAS AUTO-CYCLING. THE CUSTOMER CONFIRM THAT THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18223284 ↗
• MalfunctionNov 14, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT HIGH RATES OCCURRED DURING USE ON A PATIENT ON THE LAP TOP VENTILATOR 1150.IT WOULD JUMP FROM 14 TO 20, 30 AND BACK DOWN. THE SETTINGS ARE A/C (ASSIST-CONTROL) RATE 14, VT (TIDAL VOLUME) 500 CC, PEEP (POSITIVE END-EXPIRATORY PRESSURE) 5 AND SENSITIVITY IS 1.0. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18132573 ↗
• MalfunctionNov 1, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE BPM (BREATHS PER MINUTE) READING IS 22 WHEN IT IS SET TO 12 ON THE LAP TOP VENTILATOR 1150.THE VCALC IS ALSO READING LOW TO WHAT THEY ARE USED TO SEEING 27 LPM. 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 18052229 ↗
• MalfunctionAug 29, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THERE WAS A PATIENT ON A VERY HIGH SENSITIVITY AT 9, A/C, P/C RR 25, PEEP 8 VT 250ML ON THE LTV 1500 VENTILATOR. WHEN THEY MOVE THE PATIENT TO A STROLLER AND PLACE THE UNIT ON THE PATIENT, THEY NEED TO TURN DOWN THE SENSITIVITY TO ABOUT 7-8 SO SHE CAN TAKE A BREATH. THEY SWITCH OVER IS VERY QUICK MAYBE 30 SECONDS. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17644109 ↗
• MalfunctionAug 18, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THERE WAS A VOLUME ISSUE ON THE LTV 1150 VENTILATOR. IT WAS CONFIRMED BY THE CUSTOMER THAT THE VOLUME WAS LOW. MOREOVER, THE FLOW RATE WAS OFF. 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 17574186 ↗
• MalfunctionJun 20, 2022Temperature Problem; Temperature Problem

  THE CUSTOMER REPORTED THAT THE LTV 1150 WAS RUNNING HOT WITH ODD SQUEAK PRESENT AND HAD A PLASTIC ODOR. THERE IS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14749713 ↗
• InjuryJun 1, 2022Failure to Power Up; Failure to Power Up

  THE CUSTOMER REPORTED PROBLEM WITH LAP TOP VENTILATOR 1150 WHERE INTERNAL BATTERY FAILED CAUSING UNIT TO POWER DOWN WHILE TRANSPORTING A PATIENT FROM ER TO ICU. NO PATIENT HARM REPORTED. A STAFF IMMEDIATELY NOTED THE CONDITION AND BEGAN BAGGING THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14566854 ↗