Puritan Bennett 980U3ENASAARecalls & reported problems
Covidien LP · 980 Universal Ventilator DC Compressor Configuration · Class 2
All models of Puritan Bennett (119)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521201507), received between Jun 7, 2017 and Dec 20, 2023 — classified as 6 malfunctions.
The most frequently reported specific device problem is “No Flow” (2 reports).
1 FDA recall record name this device's identifier, 1 still open.
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.
Reports received per month
Recalls naming this device
- Mar 25, 2022Class IOpen, Classified
The audible alarm may not sound and/or the omni-directional LED visual alarm may not display during alarm states. Delayed awareness of alarm states may lead to delayed response or a delay of treatment, potentially resulting in hypoxia, dyspnea, cardiac arrest, or death.
Z-0966-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- No Flow2
- Defective Alarm1
- Device Displays Incorrect Message1
- Output Problem1
- Smoking1
Patient problems
- No Patient Involvement3
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 20, 2023No Flow; No Flow
IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS 980 VENTILATOR HAD A SHUTDOWN. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18367877 ↗MalfunctionMay 7, 2022Defective Alarm; Defective Alarm
IT WAS REPORTED WHILE IN USE ON A PATIENT THAT THIS 980 VENTILATOR HAD "EVERY SETTING ALARMING VISIBLY BUT NO AUDIBLE ALARM SOUNDED". ALTHOUGH REQUESTED, INFORMATION REGARDING THE INTERVENTION TAKEN ON THE BEHALF OF THE PATIENT IS UNKNOWN. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14316404 ↗MalfunctionMay 8, 2020No Flow; No Flow
IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, A 980 VENTILATOR "STOPPED VENTILATING" WITH AN ALARM AND MESSAGE "VENTILATION DISABLED ON SCREEN IN RED BOX." THE PATIENT WAS REMOVED FROM THE VENTILATOR AND MANUALLY VENTILATED VIA AN AMBU BAG BEFORE BEING PLACED ON AN ALTERNATE VENTILATOR. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE REPORTED EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10038738 ↗MalfunctionMay 13, 2019Output Problem; Output Problem
IT WAS REPORTED THAT A 980 VENTILATOR HAD A POWERING ON ISSUE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.
Patient problems: No Patient Involvement
MAUDE report 8604699 ↗MalfunctionApr 12, 2019Smoking; Smoking
THE CUSTOMER REPORTED THAT AT POWER UP, THE 980 VENTILATOR HAD SMOKE COMING FROM THE CENTER OF THE DEVICE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT.
Patient problems: No Patient Involvement
MAUDE report 8511880 ↗MalfunctionJun 7, 2017Device Displays Incorrect Message; Device Displays Incorrect Message
IT WAS REPORTED THAT ON START UP A 980 VENTILATOR GENERATED AN INOPERABLE ERROR MESSAGE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT. THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND VERIFIED THE REPORTED ISSUE. THE SE PERFORMED CALIBRATIONS AND EXTENDED SELF-TESTING ON THE DEVICE TO CLEAR THE ERROR MESSAGE. ALL TESTS PASSED.
Patient problems: No Patient Involvement
MAUDE report 6618357 ↗
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 · each recall links to the FDA recall notice
- 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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