LTV 1200 VENTILATOR 18888-001Recalls & reported problems
Carefusion Corporation · ASSY, LTV1200, W/ ACCESS, ENGLISH · Class 2
All models of LTV 1200 VENTILATOR (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Carefusion LTV 1200 ventilator has 323 reports, including 65 injuries and 10 deaths. Most describe mechanical faults such as unexpected shutdowns, startup fault messages, oxygen readings that are off, and air or gas leaks. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 323
- Deaths reported
- 10
- Injuries reported
- 65
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 323 adverse event reports that list this exact device (DI 00845873000364), received between Nov 26, 2018 and Dec 24, 2025 — classified as 10 deaths, 65 injuries, 248 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (224 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 Problem224
- Gas/Air Leak7
- Adverse Event Without Identified Device or Use Problem6
- Display or Visual Feedback Problem5
- Infusion or Flow Problem5
- Unexpected Shutdown5
- Battery Problem4
- Volume Accuracy Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions207
- No Information47
- No Patient Involvement30
- No Consequences Or Impact To Patient16
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available7
- No Known Impact Or Consequence To Patient5
- Death3
- Low Oxygen Saturation3
Recent adverse event reports
The 25 most recent of 323 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 24, 2025Device Alarm System; Device Alarm System
COMPLAINANT REPORTED WHILE POWERING ON, THE DEVICE SHOWED AN "INOP/HW" FAULT MESSAGE. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23888112 ↗MalfunctionJul 2, 2025Failure to Run on Battery; Failure to Run on Battery
COMPLAINT ALLEGED THAT BEFORE USE, THE DEVICE INAPPROPRIATELY SHUT DOWN WHEN UNPLUGGED. COMPLAINT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22384882 ↗MalfunctionJan 6, 2025Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT THE FIO2 WAS NOT REACHING 60%.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21081362 ↗MalfunctionJul 12, 2024Failure to Calibrate; Failure to Calibrate
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE O2 BLENDER IS DEFECTIVE DUE TO THE FIO2 READINGS. HE REPLACED THE BLENDER AND IT RESOLVED THE ISSUE. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19730411 ↗InjuryJun 10, 2024Unexpected Shutdown; Unexpected Shutdown
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE LTV 2200 VENT REPEATED SHUTDOWN AND STARTS-UP WHILE IT WAS WORKING ON PATIENT. THE VENT STARTED JUST AFTER IT WAS TURNED ON, BUT SHUTDOWN RIGHT AWAY. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19504974 ↗MalfunctionApr 22, 2024Image Display Error/Artifact; Image Display Error/Artifact
IT WAS REPORTED TO VYAIRE MEDICAL THAT SOME LED NUMBERS LIGHT UP WRONG IN THE VTE READINGS AND OTHER RESULTS ON THE DISPLAY. FOUND WHEN PERFORMING A 10K PM SO THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19153950 ↗MalfunctionMar 14, 2024Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED TO VYAIRE MEDICAL THAT UPON STARTUP THE CONNECTOR THAT GOES INTO THE O2 TRANSDUCER ON ANALOG BOARD COMES OFF WHEN O2 IS PLUGGED INTO THE UNIT CAUSING IT TO LEAK. CUSTOMER CAN'T GET THE SW VERSION AT THE MOMENT. NO PATIENT INVOLVEMENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18909238 ↗MalfunctionMar 14, 2024Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED TO THE VYAIRE MEDICAL THAT THE VENT IS FAILING THE LEAK TEST AND IS GETTING A LEAK OF 4.1. THE REPORTER PERFORMED A LEAK TEST WITH THE VENT OPEN AND DOES NOT FEEL ANY LEAKS ANYWHERE AND DOUBLE CHECKED THE TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18903453 ↗InjuryJan 31, 2024Failure to Deliver; Failure to Deliver
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE LAP TOP VENTILATOR 1200 WON'T VENTILATE WHEN CONNECTED TO THE PATIENT. THE UNIT WAS SWAPPED OUT AND THE CUSTOMER CONFIRMED THAT THERE IS NO PATIENT HARM ASSOCIATED WITH THIS REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18617186 ↗MalfunctionJan 31, 2024Activation Failure; Activation Failure
IT WAS REPORTED TO VYAIRE MEDICAL THAT VENTILATOR INOPERABLE ALARM OCCURRED ON THE LAP TOP VENTILATOR 1200. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18613407 ↗InjuryJan 18, 2024Smoking; Smoking
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE LAP TOP VENTILATOR 1200 HAD A BURNING SMELL AND FELT 'OVERHEATED.' NOTICED A CLICKING SOUND COMING FROM THE SOLENOID MOUNT DURING EACH BREATH, WHETHER THE DEVICE WAS OPEN OR CLOSED. THE UNIT WAS ON A PATIENT AT THE TIME OF THE BURNING SMELL ISSUE, BUT NO PATIENT HARM WAS REPORTED. THEY SWAPPED OUT WITH ANOTHER DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18538286 ↗MalfunctionJan 17, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO VYAIRE MEDICAL THAT CUSTOMER REQUESTED DOWNLOAD AND ANALYSIS OF THE EVENT TRACE DURING USE ON A PATIENT ON THE LAP TOP VENTILATOR 1200. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18528141 ↗MalfunctionJan 17, 2024Defective Component; Defective Component
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE LTV 1200 WOULD NOT POWER BACK ON AFTER BEING TURNED OFF. THE VENT'S BATTERY WAS CHARGED, AND THE ONLY THING THAT LIT UP WAS THE VENT'S INOP ALARM. FURTHERMORE, THERE WAS NO PATIENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18526763 ↗MalfunctionJan 2, 2024Disconnection; Disconnection
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE LTV 1200 WAS AUTO-CYCLING WHILE ON A PATIENT, THE UNIT GOT A DISCONNECT ALARM AND THE VENT WENT INOP. FURTHERMORE, THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18432557 ↗MalfunctionJan 2, 2024Failure to Auto Stop; Failure to Auto Stop
IT WAS REPORTED TO VYAIRE MEDICAL THAT DEVICE WAS AUTO-CYCLING WHILE ON A PATIENT ON THE LAP TOP VENTILATOR 1200. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18432552 ↗InjuryDec 29, 2023Failure to Conduct; Failure to Conduct
THE CUSTOMER REPORTED TO VYAIRE MEDICAL A PROBLEM WITH THE LAPTOP 1200 VENTILATOR REGARDING XDCR (TRANSDUCER) FAULT WHILE UNIT WAS ON A PATIENT. FURTHERMORE, THERE WAS NO PATIENT HARM REPORTED ASSOCIATED WITH THE EVENT. THE PATIENT WAS SWAPPED TO ANOTHER VENTILATOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18419214 ↗MalfunctionDec 29, 2023Defective Component; Defective Component
THE CUSTOMER REPORTED TO VYAIRE MEDICAL PROBLEM WITH THE LAPTOP 1200 VENTILATOR WHERE A VENT INOP (INOPERABLE) ALARM OCCURRED WHILE THE UNIT WAS ON A PATIENT. FURTHERMORE, THERE WAS NO PATIENT HARM REPORTED ASSOCIATED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18419170 ↗MalfunctionDec 15, 2023Defective Component; Defective Component
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE LAP TOP VENTILATOR HAS BAD MOTOR BOARD. THE CUSTOMER CONFIRMED THAT THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18335895 ↗MalfunctionDec 15, 2023Volume Accuracy Problem; Volume Accuracy Problem
IT WAS REPORTED TO VYAIRE MEDICAL THAT REPORTED TO VYAIRE MEDICAL THAT OXYGEN WAS OUT SPECIFICATION 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 18334660 ↗MalfunctionDec 14, 2023Inaccurate Flow Rate; Inaccurate Flow Rate
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE LTV 1200 OXYGEN CONCENTRATION WAS OUT OF TOLERANCE. FURTHERMORE, THERE WAS NO INFORMATION FOR PATIENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18332845 ↗MalfunctionDec 14, 2023Inaccurate Flow Rate; Inaccurate Flow Rate
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE LTV 1200 OXYGEN CONCENTRATION WAS OUT OF TOLERANCE. FURTHERMORE, THERE WAS NO INFORMATION FOR PATIENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18327286 ↗MalfunctionDec 14, 2023Inaccurate Flow Rate; Inaccurate Flow Rate
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE LTV 1200 OXYGEN CONCENTRATION WAS OUT OF TOLERANCE. FURTHERMORE, THERE WAS NO INFORMATION FOR PATIENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18326959 ↗MalfunctionDec 13, 2023Unexpected Shutdown; Unexpected Shutdown
IT WAS REPORTED TO VYAIRE MEDICAL THAT THE LTV 1200 TURNED OFF WHILE IN USE ON PATIENT WHILE ON BATTERY POWER AND WHEN PLUGGED IN. FURTHERMORE, THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18320314 ↗MalfunctionDec 12, 2023Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED TO VYAIRE MEDICAL THAT THERE IS A LEAK ON THE 02 BLENDER SIDE AT THE TUBING OF THE LAP TOP 1200 VENTILATOR. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18314999 ↗MalfunctionDec 1, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
HOLD FOR KH 12/01 THE CUSTOMER REPORTED TO VYAIRE MEDICAL PROBLEM WITH THE LAPTOP 1200 VENTILATOR IN WHICH FIO2 (FRACTION OF INSPIRED OXYGEN) IS OUT OF SPECIFICATION. FURTHERMORE, THERE WAS NO INFORMATION REGARDING PATIENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18248396 ↗
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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