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LTV 10130 (UDI 10190752114067)Recalls & reported problems

Vyaire Medical, Inc. · LTV 1000 Ventilator, English · Class 2

Adverse event reports
5
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10190752114067), received between Nov 15, 2021 and Jan 10, 2022 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (4 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 Problem4
  • Device Alarm System1

Patient problems

  • No Clinical Signs, Symptoms or Conditions5

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • InjuryJan 10, 2022Mechanical Problem; Mechanical Problem

    THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE LAP TOP 1000 VENTILATOR OCCURRED LOW TIDAL VOLUME. THE ISSUE OCCURRED DURING PATIENT-USE AND THE DEVICE REMOVED FROM THE PATIENT. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13212852 ↗
  • MalfunctionDec 16, 2021Mechanical Problem; Mechanical Problem

    THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE LAP TOP VENTILATOR 1000 RESET WHILE ON A PATIENT. THE CUSTOMER CONFIRMED THAT THERE IS NO PATIENT HARM ASSOCIATED WITH THIS REPORTED EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13022767 ↗
  • MalfunctionDec 14, 2021Device Alarm System; Device Alarm System

    REASON FOR RETURN: THE CUSTOMER REPORTED THAT THE LTV VENTILATOR UNIT WAS NOT ABLE TO ALARM WHEN PATIENT'S TRACH WAS DECANNULATED, STILL HOOKED TO END OF CIRCUIT. 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 13005943 ↗
  • MalfunctionNov 22, 2021Mechanical Problem; Mechanical Problem

    THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE LAP TOP VENTILATOR 1000 TURNS ON BY ITSELF. 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 12856893 ↗
  • MalfunctionNov 15, 2021Mechanical Problem; Mechanical Problem

    THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE LAP TOP 1000 VENTILATOR SHUT OFF WHILE ON A PATIENT. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT HARM WITH THE REPORTED EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12816924 ↗

Other Ventilator, continuous, facility use devices

All Ventilator, continuous, facility use devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.