Puritan Bennett 980X3DEDRACRecalls & reported problems
Covidien LP · 980 Ventilator 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521172579), received between Apr 11, 2017 and Jul 31, 2017 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Displays Incorrect Message” (1 report).
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.
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
- Device Displays Incorrect Message1
- Insufficient Device Problem Information1
Patient problems
- No Code Available1
- 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.
MalfunctionJul 31, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE OXYGEN (O2) SENSOR IN A 980 VENTILATOR WOULD NOT CALIBRATE AND AN ALARM WAS GENERATED. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT. THE SERVICE ENGINEER (SE) REPLACED THE O2 SENSOR. THE VENTILATOR WAS CALIBRATED. THE UNIT PASSED ALL TESTING AND OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS.
Patient problems: No Patient Involvement
MAUDE report 6754609 ↗InjuryApr 11, 2017Device Displays Incorrect Message; Device Displays Incorrect Message
IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, THE 980 VENTILATOR GENERATED ERROR MESSAGES. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE REPORTED EVENT. THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE. THE SE REPLACED THE LINE INTERFACE PRINTED CIRCUIT BOARD (PCB) AND PERFORMED CALIBRATIONS AND EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED.
Patient problems: No Code Available
MAUDE report 6483673 ↗
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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