Puritan Bennett 4-840120DIJJ-NJRecalls & reported problems
Covidien LP · 800 Series Ventilator System,Model 840 · Class 2
All models of Puritan Bennett (119)
Data updated Oct 18, 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 10884521076907), received between Aug 16, 2019 and Mar 26, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “No Flow” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- No Flow1
- Smoking1
Patient problems
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 26, 2020Smoking; Smoking
IT WAS REPORTED THAT WHILE IN USE THIS 840 VENTILATOR HAD "A BATTERY-POWERED ALARM SOUNDING AT THE TIME OF AC CONNECTION ALARM SOUNDS SCREEN DISPLAY DISAPPEARS, SMOKE CAME OUT FROM THE RESPIRATORY BODY." THE PATIENT WAS REMOVED FROM THE VENTILATOR AND HAND VENTILATED WITH NO HARM REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9886352 ↗MalfunctionAug 16, 2019No Flow; No Flow
IT WAS REPORTED THAT DURING USE THE 840 VENTILATOR STOPPED VENTILATION AND SAFETY VALVE WENT OPEN. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITHOUT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8902934 ↗
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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