LTV 19222-201Recalls & reported problems
Vyaire Medical, Inc. · LTV Sprintpack w/Bracket · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 10190752115682), received between Apr 6, 2021 and Apr 20, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (1 report).
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
- Overheating of Device1
- Smoking1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 20, 2022Smoking; Smoking
THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE LTV SPRINTPACK W/BRACKET WHEN PLACED ON A PATIENT'S HOME STARTED SMOKING. IMMEDIATELY REMOVED WITH NO MELTING OR BLACKENING NOTED. THERE IS NO HARM TO PATIENT ASSOCIATED WITH THE REPORTED EVENT. ADDITIONALLY, THE CUSTOMER CONFIRMED THAT NO ALTERNATE VENTILATION WAS NEEDED DURING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14164474 ↗MalfunctionApr 6, 2021Overheating of Device; Overheating of Device
THE CUSTOMER REPORTED THAT THE LAP TOP VENTILATOR 1000 EXPERIENCED BURN MARKS AROUND SPRINTPACK AND THE BATTERY. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11624945 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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