LTV 1200 VENTILATOR 18888-201 (UDI 10190752115637)Recalls & reported problems
Vyaire Medical, Inc. · LTV 1200 Ventilator, MRI Conditional, English · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10190752115637), received between May 18, 2022 and Aug 4, 2025 — classified as 3 injuries, 7 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.
Reports received per month
Most reported problems
Device problems
- Mechanical Problem2
- Pressure Problem2
- Failure to Run on Battery1
- Failure to Sense1
- Low Readings1
- Noise, Audible1
- Power Problem1
- Volume Accuracy Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- Insufficient Information1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 4, 2025Failure to Sense; Failure to Sense
IT WAS REPORTED THAT THERE WAS A PROBLEM WITH THE BREATH RATE FUNCTION OF THE DEVICE. THERE WAS NO MENTION OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22703527 ↗MalfunctionJul 1, 2025Noise, Audible; Noise, Audible
COMPLAINTANT ALLEGED THAT BEFORE USE, THE DEVICE WAS EXPERIENCING A CLICKING NOISE NEAR THE O2 INLET. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22370619 ↗MalfunctionJul 11, 2024Failure to Run on Battery; Failure to Run on Battery
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VENTILATOR FAILED DURING USE. IT SHUT OFF AND GAVE CODE ""BATT INOP ERROR". UNKNOWN PATIENT STATUS. RECEIVED MEDWATCH REPORT FROM COMPLAINT TEAM.
Patient problems: Insufficient Information
MAUDE report 19721364 ↗InjuryJun 27, 2024Low Readings; Low Readings
IT WAS REPORTED TO VYAIRE MEDICAL, THE CUSTOMER REPORTED LOW O2 PRESS ALARM WHILE VENT WAS ON PATIENT. THE CUSTOMER REPORTED THAT PATIENT DESATURATED BUT WAS NOT INJURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19629676 ↗MalfunctionNov 27, 2023Pressure Problem; Pressure Problem
THE CUSTOMER REPORTED TO VYAIRE MEDICAL PROBLEM WITH THE LAPTOP 1200 VENTILATOR A PERSISTENT O2 (OXYGEN) PRESSURE LOW ALARM. FURTHERMORE, THERE WAS NO PATIENT HARM REPORTED ASSOCIATED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18208784 ↗MalfunctionNov 24, 2023Volume Accuracy Problem; Volume Accuracy Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT A HIGH POSITIVE END-EXPIRATORY PRESSURE (PEEP) ALERT WHEN THE LTV 1200 IS SET TO 5, AND EVEN AT 2, AND THE TEST LUNGS APPEAR TO BE ABOUT TO RUPTURE. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18205904 ↗MalfunctionSep 12, 2023Power Problem; Power Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT CONSTANT POWER LOSS OCCURRED ON THE LAP TOP VENTILATOR 1200. 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 17731287 ↗MalfunctionJan 31, 2023Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE LTV 1200 VENTILATOR ALARMED HW FAULT DURING PATIENT USE WHILE IN THE MRI. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16275559 ↗InjuryJan 30, 2023Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED THAT THE UNIT WAS ALARMING LOW BATTERY WITH A RED BATTERY CHARGE LEVEL INDICATOR DURING PATIENT USE IN THE MRI. FURTHERMORE, THE PATIENT WAS QUICKLY VENTILATED MANUALLY AND THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16268053 ↗InjuryMay 18, 2022Pressure Problem; Pressure Problem
THE CUSTOMER REPORTED TO VYAIRE MEDICAL PROBLEMS WITH LAP TOP VENTILATOR 1200. THE RESPIRATORY THERAPIST NOTED A HIGH PRESSURE READING, BUT INACCURATE. THE VENT IS ALSO DUE FOR PM. FURTHERMORE, THE CUSTOMER CONFIRMED THAT ALTERNATIVE VENTILATION WAS PROVIDED TO THE PATIENT. RESPIRATORY THERAPIST WAS ABLE TO SWITCH THE VENTILATOR AND THERE WAS NO PATIENT HARM REPORTED ASSOCIATED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14432075 ↗
Other Ventilator, continuous, facility use devices
- Trilogy Trilogy100 Ventilator, United StatesRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE92 deaths8,161 reports
- Trilogy Evo Trilogy Evo, USARespironics, Inc. · Ventilator, continuous, facility use6 recalls50 deaths4,393 reports
- Trilogy 100 Trilogy 100 W/ Bluetooth, USARespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE65 deaths4,569 reports
- CARESCAPE R860Datex-Ohmeda Inc · VENTILATOR, CONTINUOUS, FACILITY USE1 recall1 death4,346 reports
- HAMILTON-C1 161001Hamilton Medical AG · Ventilator, Continuous, Facility Use2 recalls12 deaths1,849 reports
- Trilogy Trilogy O2 Ventilator JapanRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE7 deaths1,900 reports
- Trilogy Trilogy 202 Ventilator InternationalRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE11 deaths1,564 reports
- HAMILTON-C6 160021Hamilton Medical AG · Ventilator, Continuous, Facility Use5 recalls10 deaths1,175 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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