Puritan Bennett 980X1ENDIUU-RMFRecalls & reported problems
Covidien LP · 980 Ventilator Remanufactured · Class 2
All models of Puritan Bennett (119)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521592810), received between Feb 21, 2019 and Oct 10, 2019 — classified as 3 malfunctions.
The most frequently reported specific device problem is “No Flow” (2 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
Device problems
- No Flow2
- Defective Alarm1
Patient problems
- No Consequences Or Impact To Patient2
- No Code Available1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 10, 2019No Flow; No Flow
IT WAS REPORTED THAT DURING USE ON A PATIENT, THE 980 VENTILATOR SHUT DOWN. THE PATIENT WAS TRANSFERRED TO AN ALTERNATE VENTILATOR WITH NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9176265 ↗MalfunctionSep 4, 2019No Flow; No Flow
IT WAS REPORTED THAT DURING USE ON A PATIENT, THE 980 VENTILATOR SHUT DOWN. THE PATIENT WAS TRANSFERRED TO AN ALTERNATE VENTILATOR WITH NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8962504 ↗MalfunctionFeb 21, 2019Defective Alarm; Defective Alarm
IT WAS REPORTED THAT THE 980 VENTILATOR WAS BEING USED ON A PATIENT IN VOLUME CONTROL PLUS MODE WITH THE VOLUME SET TO 390ML. THE PATIENT WAS SUCCESSFULLY WEANED FROM VOLUME CONTROL PLUS TO PRESSURE SUPPORT; HOWEVER, WITHIN A FEW MINUTES THE TIDAL VOLUME BEGAN TO READ 3000 ML TO 6000 ML WITHOUT ANY ALARMS. THE PATIENT WAS PLACED ON AN ALTERNATE VENTILATOR WITH NO PATIENT HARM.
Patient problems: No Code Available
MAUDE report 8360087 ↗
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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