LTV 18881-001Recalls & reported problems
Carefusion Corporation · MR CONDITIONAL LTV 1200 SYSTEM · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00845873000913), received between Nov 25, 2020 and Feb 5, 2021 — classified as 2 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Mechanical Problem2
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 5, 2021Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VENTILATOR WENT INOPERABLE. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11289253 ↗MalfunctionNov 25, 2020Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE LAP TOP VENTILATOR 1200, EXHALED TIDAL VOLUME (VTE) READING WAS HIGHER THAN THE SET TIDAL VOLUME. THE ISSUE HAPPENED WHEN AN INTUBATED PATIENT WAS PLACED ON THE VENTILATOR ON VOLUME CONTROL MODE WITH SET VT 580ML AND EXHALED VTE IS 700-800 ML. INITIALLY ATTRIBUTED TO ASYNCHRONY SO PLACED PATIENT ON PATIENT CONTROL MODE WHERE THE VOLUMES WERE BETTER CONTROLLED. 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 10901006 ↗
Other Ventilator, Continuous, Facility Use devices
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- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.