LTV 1200 VENTILATOR 18888-201 (UDI 00845873002696)Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00845873002696), received between Mar 22, 2019 and Dec 30, 2025 — classified as 11 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (28 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 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2025Device Alarm System; Device Alarm System

  CUSTOMER STATED THAT THE UNIT ALARMED WITH A HARDWARE FAULT ERROR MESSAGE WHILE BEING USED ON A PATIENT BUT KEPT VENTILATING. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23926757 ↗
• MalfunctionDec 4, 2025Device Alarm System; Device Alarm System

  THE CUSTOMER REPORTED THAT WHILE THE UNIT WAS BEING TRANSPORTED INTO AN MRI ROOM, THEY OBSERVED THAT THE VENT WAS INDICATING AN HW FAULT ALARM. THEY SECURED THE PATIENT IN A BAG, AND THE PATIENT WAS SUBSEQUENTLY TRANSFERRED TO ANOTHER LTV. NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23718156 ↗
• InjuryMay 24, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE DEVICE WAS PULLED INTO THE MRI. PATIENT WAS INVOLVED BUT NO PATIENT HARM OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19392238 ↗
• MalfunctionDec 13, 2023Pressure Problem; Pressure Problem

  IT WAS REPORTED TO VYAIRE MEDICAL PROBLEM WITH THE LAPTOP 1200 VENTILATOR IN WHICH A DEFECTIVE SOLENOID MANIFOLD IS CAUSING HIGH AND LOW PEEP (POSITIVE END-EXPIRATORY PRESSURE) ALARMS DURING USE. FURTHERMORE, THERE WAS NO PATIENT HARM REPORTED ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18321402 ↗
• MalfunctionNov 13, 2023Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL PROBLEM WITH THE LAPTOP 1200 VENTILATOR. THE MAGNETIC RESONANCE-CONDITIONAL VENTILATOR SHIPPED WITH A MAGNETIC CABLE SUPPORT BRACKET ON THE PORTABLE BACKUP BATTERY UNIT. THERE IS NO INDICATION ON THE BRACKET, BATTERY, VENTILATOR, PRODUCT PACKAGING, OR OTHERWISE THAT THE MR CONDITIONAL EQUIPMENT CONTAINED THE MAGNETIC BRACKET. THE BRACKET, ALONG WITH THE VENTILATOR WHICH WAS IN-USE ON A PATIENT WAS PULLED INTO THE MRI (MAGNETIC RESONANCE IMAGING) MACHINE'S BORE OPENING. FURTHERMORE, THERE WAS NO PATIENT HARM REPORTED ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18120107 ↗
• MalfunctionSep 25, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT UNIT STOPPED WORKING DURING AN ANIMAL STUDY ON THE LAP TOP VENTILATOR 1200. THE UNIT GAVE AN ERROR MESSAGE OF BATTERY ISSUES. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17814833 ↗
• MalfunctionJun 15, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE LAP TOP VENTILATOR 1200 NOT CHARGING AFTER 8+ HOURS PLUGGED INTO WALL BUT SHOWS CHARGE STATUS AS RED AND ALARMS VENT INOP (VENTILATOR INOPERABLE) WHEN POWERED ON. UNIT WAS ON A PATIENT 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 14707526 ↗
• MalfunctionApr 25, 2022Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL AN INFORMATIONAL MESSAGE WITH LTV 1200 REGARDING LPPS CODE ON UNIT. AS PER OPERATIONS MANUAL, THIS IS AN INDICATION OF LOW MINUTE VOLUME ALARM IS TURNED OFF. FURTHERMORE, THERE WAS NO PATIENT ASSOCIATED WITH THE REPORTED EVENT AS THE EVENT HAPPENED DURING SETUP PRIOR PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14197798 ↗
• MalfunctionJan 3, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE LTV 1200 VENTILATOR IS GETTING DISTORTED ARTIFACTS WHEN IN USE. 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 13142517 ↗
• MalfunctionDec 28, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE LTV 1200 VENTILATOR UNIT WAS NOT RECORDING VOLUMES. 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 13097890 ↗
• MalfunctionDec 20, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED NO VOLUMES 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 13048057 ↗
• MalfunctionNov 8, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL DISC SENSE ERROR ON LAP TOP VENTILATOR. 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 12775664 ↗
• MalfunctionOct 16, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE LAP TOP VENTILATOR 1200 WORKS FINE FOR ABOUT 5-10 MIN OR SO AND THEN IT STARTS AUTO-CYCLING AND GIVING DIFFERENT ALARMS. THE CUSTOMER CONFIRMED THAT THERE IS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12643813 ↗
• MalfunctionOct 14, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE LAP TOP VENTILATOR HAS AN AUTO-CYCLING ISSUE. THE REPORTER CONFIRMED THAT THERE IS A PATIENT INVOLVEMENT ASSOCIATED ON THIS EVENT. HOWEVER, NO HARM NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12634744 ↗
• MalfunctionOct 1, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT THE LAP TOP VENTILATOR 1200 GOT SUCKED UP INTO MRI MACHINE. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12562966 ↗
• MalfunctionSep 13, 2021Material Integrity Problem; Material Integrity Problem

  IT IS REPORTED TO VYAIRE MEDICAL THAT THE LTV 1200 EXPERIENCED BEING PULLED TOWARDS THE MRI WHILE A PATIENT IS BEING TRANSPORTED. THE VENTILATION CONTINUED WORKING BUT DISPLAYED HW FAULT ERROR MESSAGE. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12463523 ↗
• InjuryAug 26, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE LAP TOP VENTILATOR UNIT WAS NOT CHARGING. ALSO CUSTOMER NOTED IT HAS A NO FLOW ISSUE. THE REPORTER CONFIRMED THAT THERE IS A PATIENT INVOLVEMENT ASSOCIATED ON THIS EVENT. HOWEVER, NO HARM NOTED. AS AN INTERVENTION, VENTILATOR WAS STOPPED AND THE RT BAGGED THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12375538 ↗
• InjuryAug 24, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED DEVICE STOPPED VENTILATING WHILE IN PATIENT USE ON THE LAP TOP VENTILATOR 1200. THE CUSTOMER REPORTED THE PATIENT WAS REMOVED FROM THE VENTILATOR AND RESPIRATORY THERAPIST BEGAN TO MANUAL RESUSCITATE ( BAG ) THE PATIENT. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12362188 ↗
• MalfunctionApr 23, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE CUSTOMER REPORTED IMAGE PROBLEMS WHILE IN USE DURING THE MAGNETIC RESONANCE IMAGING 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 11712880 ↗
• InjuryApr 20, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE LAP TOP VENTILATOR 1200 UNIT IS NOT FUNCTIONING AS INTENDED WHILE ON A PATIENT. THE THERAPIST STARTED TO DO MANUAL VENTILATION TO THE PATIENT AND CONFIRMED THAT THERE IS NO HARM NOTED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11694562 ↗
• InjuryApr 15, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE LAP TOP VENTILATOR 1200 ALARMED LOW MINUTE VENT VOLUME WHILE CONNECTED TO A PATIENT. AS AN INTERVENTION, THEY SUCTIONED THE PATIENT AND PLACED VENTILATOR BACK ON, BUT THE DEVICE STILL ALARMING ALERTING OF LOW MIN VENT. THEY BAGGED THE PATIENT UNTIL NEW MRI ARRIVED AND X-RAY WAS TAKEN ENDOTRACHEAL TUBE (ETT) APPEARS TO BE IN GOOD PLACEMENT. 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 11673395 ↗
• MalfunctionApr 5, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE THAT THE LAP TOP VENTILATOR 1200 WAS ON A PATIENT BEING SCAN WITH MRI (MAGNET RESONANCE IMAGING) ALARMED VENT INOP (VENTILATOR INOPERABLE) AND KEPT CYCLING ON AND OFF. THE CUSTOMER CONFIRMED THAT THERE IS NO PATIENT HARM ASSOCIATED WITH THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11615568 ↗
• MalfunctionFeb 15, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE LTV (LAP TOP VENTILATOR) 1200 SHUT OFF WHILE ON A PATIENT AND EXPERIENCED VENTILATOR INOPERABLE. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11328836 ↗
• InjuryFeb 4, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT WHILE USING THE LAP TOP VENTILATOR 1200 ON A PATIENT THAT IS IN MRI (MAGNETIC RESONANCE IMAGING) MACHINE, THE PATIENT DESATURATED AND NOTICED THAT THE PATIENT HAD NO CHEST RISE AND BECAME PULSELESS. CODE WAS INITIATED AND ROSC (RETURN OF SPONTANEOUS CIRCULATION) WAS ACHIEVED AFTER ONE ROUND OF EPINEPHRINE AND COMPRESSIONS. THE PATIENT WAS MANUALLY VENTILATED AND RETURNED TO THE ICU (INTENSIVE CARE UNIT).

  Patient problems: Low Oxygen Saturation

  MAUDE report 11283413 ↗
• InjuryFeb 4, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE LAP TOP VENTILATOR 1200 ALARMED HARDWARE FAULT AND THE VENTILATION STOPPED. THE ISSUE OCCURRED DURING PATIENT-USE AND THE DEVICE WAS REPLACED WITH ANOTHER VENTILATOR. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11283333 ↗