Puritan Bennett 4-840220DIUB-ENRecalls & 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 10884521183513), received between Apr 5, 2017 and Aug 18, 2017 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure of Device to Self-Test” (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
- Failure of Device to Self-Test1
- No Display/Image1
Patient problems
- No Information1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 18, 2017Failure of Device to Self-Test; Failure of Device to Self-Test
IT WAS REPORTED THAT, AN 840 VENTILATOR HAD A BREATH DELIVERY (BD) POWER ON SELF-TEST (POST) ISSUE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THE EVENT OCCURRED. THE SERVICE ENGINEER (SE) VERIFIED THE ISSUE AND REPLACED THE BREATH DELIVERY UNIT (BDU) PRINTED CIRCUIT BOARD (PCB) AND UPGRADED THE SOFTWARE TO THE LATEST VERSION. THE UNIT PASSED ALL TESTING AND OPERATED WITHIN THE MANUFACTURER SPECIFICATIONS.
Patient problems: No Patient Involvement
MAUDE report 6805627 ↗MalfunctionApr 5, 2017No Display/Image; No Display/Image
IT WAS REPORTED THE VENTILATOR'S DISPLAY WAS BLANK. PATIENT INVOLVEMENT INFORMATION WAS NOT PROVIDED BY THE CUSTOMER. REPAIR WILL BE COMPLETED AT A NON-MEDTRONIC LOCATION AND THE PRODUCT IS NOT IN MEDTRONIC CONTROL. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED WITHOUT THE PRODUCT RETURN. THE COMPLAINT WILL BE CLOSED AND REOPENED/UPDATED SHOULD NEW INFORMATION BECOME AVAILABLE OR IF THE PRODUCT IS RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THE INFORMATION HAS BEEN ADDED TO THE DATABASE FOR TRENDING PURPOSES AND TRENDS WILL CONTINUE TO BE MONITORED. A CAPA IS NOT REQUIRED AT THIS TIME.
Patient problems: No Information
MAUDE report 6461194 ↗
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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