LTV 1150 VENTILATOR 18984-001 (REF 18984-001, 18984-001-99)Recalls & reported problems

Summary

The FDA's MAUDE database contains 227 adverse event reports that list this exact device (DI 00845873002726), received between Dec 1, 2018 and May 5, 2025 — classified as 51 deaths, 32 injuries, 144 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (132 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 25 most recent of 227 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2025Failure to Deliver; Failure to Deliver

  COMPLAINANT ALLEGED THAT DURING USE ON A PATIENT, THE DEVICE WAS NOT BLOWING AIR. FIRST RESPONDERS PLACED PATIENT ON TRANSPORT VENTILATOR AND WAS SENT TO HOSPITAL. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21961152 ↗
• DeathSep 24, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT A PEDIATRIC PATIENT WAS ON THE LTV 1150 DEVICE VIA A TRACHEOSTOMY TUBE. ON THE MORNING OF (B)(6), THE DAY-SHIFT NURSE ARRIVED TO FIND THE TRACHEOTOMY HAD BECOME DISLODGED AT SOME POINT DURING THE EVENING AND WAS UNABLE TO GET A PULSE READING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20292073 ↗
• MalfunctionMay 20, 2024Display Difficult to Read; Display Difficult to Read

  IT WAS REPORTED TO VYAIRE MEDICAL DEAD PIXELS WAS DISPLAYED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19355478 ↗
• InjuryMay 20, 2024High Readings; High Readings

  IT WAS REPORTED THAT 900 F/VT 57 F ERROR WHILE THE UNIT WAS BEING USED BY A PATIENT. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19353086 ↗
• MalfunctionApr 29, 2024No Display/Image; No Display/Image

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THEY RECEIVED PO FOR NEW MAIN BOARD DUE TO LEDS ON DISPLAY ARE NOT ILLUMINATING. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19209903 ↗
• MalfunctionMar 27, 2024Display Difficult to Read; Display Difficult to Read

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE LAP TOP VENTILATOR 1150 HAS A MISSING SEGMENTS ON DISPLAY. 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 18986184 ↗
• MalfunctionJan 10, 2024Image Display Error/Artifact; Image Display Error/Artifact

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL PROBLEM WITH THE LAPTOP 1150 VENTILATOR WHERE THE PIXELS WERE MISSING FROM THE DISPLAY. FURTHERMORE, THERE WAS NO PATIENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18484351 ↗
• MalfunctionJan 9, 2024Image Display Error/Artifact; Image Display Error/Artifact

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL PROBLEM WITH THE LAPTOP 1150 VENTILATOR WHERE THE PIXELS WERE MISSING FROM THE DISPLAY. FURTHERMORE, THERE WAS NO PATIENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18477466 ↗
• MalfunctionJan 2, 2024Tidal Volume Fluctuations; Tidal Volume Fluctuations

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL PROBLEM WITH THE LAPTOP 1150 VENTILATOR. THE UNIT WAS FAILING PATIENT OUTLET PRESSURE PERFORMANCE CHECK,HAD BENTS PINS AND VT (TIDAL VOLUME) WAS OUT OF SPECIFICATION.FURTHERMORE, THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18429397 ↗
• MalfunctionDec 14, 2023Failure to Cycle; Failure to Cycle

  IT WAS REPORTED TO VYAIRE MEDICAL PROBLEM WITH THE LAPTOP 1150 VENTILATOR WHICH HAD A DEFECTIVE TURBINE THAT WOULD NOT CYCLE. FURTHERMORE, THERE WAS NO INFORMATION REGARDING PATIENT ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18324903 ↗
• DeathDec 1, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THERE WAS A PATIENT 'INCIDENT' ON THE LTV 1150 AND WANTED AN EVENT TRACE. THE PATIENT EXPIRED.

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

  MAUDE report 18248605 ↗
• MalfunctionNov 30, 2023Pressure Problem; Pressure Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE LAP TOP VENTILATOR 1150 IS READING AIRWAY PRESSURE WITH NO CIRCUIT INSTALLED AND ALARMS XDCR FAULTS. FOUND CORROSION (FLUID INTRUSION) ON POWER PCB AND ON SOLENOID MANIFOLD. 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 18241725 ↗
• MalfunctionNov 29, 2023Noise, Audible; Noise, Audible

  IT WAS REPORTED TO VYAIRE MEDICAL THAT LAP TOP VENTILATOR 1150 HAS NOISE WITH PATIENT EFFORT. 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 18234645 ↗
• MalfunctionNov 28, 2023Mechanical Jam; Mechanical Jam

  IT WAS REPORTED TO VYAIRE MEDICAL THAT TURBINE SEIZED ON THE LAP TOP VENTILATOR 1150. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18223314 ↗
• MalfunctionOct 10, 2023Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL PROBLEM WITH THE LAPTOP 1150 VENTILATOR IN WHICH A VENT INOP (INOPERABLE) ALARM COMES ON WHEN THE UNIT IS OFF AND COMES BACK ON A FEW SECONDS AFTER THE RESET/SILENCE BUTTON IS HIT. THE ALARM SILENCE WORKS FINE FOR ALL OTHER ALARMS. THE ONLY WAY TO TURN THE ALARM OFF IS TO DISCONNECT THE POWER PACK. FURTHERMORE, THERE WAS NO INFORMATION REGARDING PATIENT ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17906492 ↗
• MalfunctionSep 25, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE LAP TOP VENTILATOR 1150 BOARD BEING REPLACED DUE TO BURNT OUT LEDS. THE CUSTOMER CONFIRMED THAT THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17814364 ↗
• MalfunctionAug 29, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT 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. THE 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 17643986 ↗
• MalfunctionJul 28, 2023Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL PROBLEM WITH THE LAPTOP 1150 VENTILATOR WHERE VENTILATOR IS ALARMING DISC/SENSE. UNIT DOES NOT WANT TO BLOW ANY AIR. FURTHERMORE, THERE WAS NO INFORMATION REGARDING PATIENT ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17420154 ↗
• MalfunctionJul 17, 2023Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED TO VYAIRE MEDICAL THAT BURNT OUT LIGHT EMITTING DIODES OCCURRED ON THE LAP TOP VENTILATOR 1150. 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 17331021 ↗
• MalfunctionJul 11, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE LAP TOP VENTILATOR 1150 BPM IS READING 34 WHEN SET TO 12. AS OF THIS TIME THERE IS NO INFORMATION OF PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17302823 ↗
• InjuryJul 11, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO VYAIRE MEDICAL THAT A PATIENT INCIDENT HAS OCCURRED ON THE LTV 1150 VENTILATOR. THERE IS NO INFORMATION ON THE DETAILS OF THE INCIDENT ITSELF AND REGARDING PATIENT HARM OR INJURY ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17302767 ↗
• InjuryJul 11, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE LTV 1150 VENTILATOR WILL BE COMING IN FOR AN EVENT TRACE DUE TO PATIENT INCIDENT. AT THIS TIME CUSTOMER DID NOT PROVIDE FURTHER DETAILS OF THE INCIDENT. 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 17302755 ↗
• InjuryJun 29, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE A BATTERY FAILURE HAS OCCURRED ON THE LTV 1150 VENTILATOR WHICH EVENTUALLY SHUT DOWN DURING PATIENT USE. IT WAS STATED THAT THE UNIT WAS NOT EVEN CHARGING. FURTHERMORE, THE PATIENT WAS TRANSFERRED TO ANOTHER DEVICE AND THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17222701 ↗
• InjuryMar 1, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE LTV 1150 VENTILATOR DID NOT SOUND LIKE IT WAS WORKING PROPERLY AND PATIENT'S OXYGEN SATURATIONS WERE 'LOW' WITH NOTED LITTLE CHEST RISE. FURTHERMORE, THE PATIENT WAS TRANSFERRED TO ANOTHER DEVICE AND OXYGEN SATURATIONS RETURNED TO NORMAL. IT WAS ALSO STATED THAT THE TURBINE DID NOT RUN AT ALL WHEN UNIT WAS POWERED ON. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: Low Oxygen Saturation

  MAUDE report 16461509 ↗
• DeathFeb 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT A PATIENT DEATH HAS OCCURRED BUT NOT ON THE LTV 1150 VENTILATOR DURING TIME OF DEATH.

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

  MAUDE report 16413840 ↗