Puritan Bennett 980S1ESDIUARecalls & reported problems
Covidien LP · 980 Pediatric-Adult Ventilator · 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
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521201224), received between Sep 5, 2018 and Apr 29, 2021 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Improper Flow or Infusion” (5 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.
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
- Improper Flow or Infusion5
- No Flow1
- Smoking1
Patient problems
- Low Oxygen Saturation4
- Apnea1
- No Code Available1
- No Information1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 29, 2021Improper Flow or Infusion; Improper Flow or Infusion
IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE 980 VENTILATOR STOPPED VENTILATING THE PATIENT AND DISPLAYED "VENTILATOR INOPERA TIVE-REPLACE VENTILATOR". THE PATIENT WAS NOTED TO THEN HAVE APNEA. THE PATIENT WAS PLACED ON AN ALTERNATE VENTILATOR AND ALTHOUGH THE EVENT WAS NOTED TO LEAD TO EXTENDED PATIENT HOSPITALIZATION, THERE WAS NO HARM TO THE PATIENT. PER REVIEW OF THE LOGS, THE VENTILATOR HAD ENTERED BACK UP VENTILATION AT THE TIME OF THE REPORTED EVENT.
Patient problems: Apnea
MAUDE report 11750102 ↗MalfunctionFeb 16, 2020Smoking; Smoking
IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, A 980 VENTILATOR SHUT DOWN AND THERE WAS SMOKE BY THE BACK OF THE GRAPHICAL USER INTERFACE (GUI). THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO HARM OR INJURY.
Patient problems: No Information
MAUDE report 9715276 ↗MalfunctionOct 29, 2018No Flow; No Flow
IT WAS REPORTED THAT, UPON CONNECTING A PATIENT TO A 980 VENTILATOR, THE VENTILATOR GENERATED AN ALARM AND IT DID NOT ¿START TO VENTILATE¿. 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.
Patient problems: No Code Available
MAUDE report 8017527 ↗MalfunctionSep 5, 2018Improper Flow or Infusion; Improper Flow or Infusion
IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, A 980 VENTILATOR ENTERED INTO BACKUP VENTILATION. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR. THE PATIENT DESATURATED.
Patient problems: Low Oxygen Saturation
MAUDE report 7848562 ↗MalfunctionSep 5, 2018Improper Flow or Infusion; Improper Flow or Infusion
IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, A 980 VENTILATOR ENTERED INTO BACKUP VENTILATION. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR. THE PATIENT DESATURATED.
Patient problems: Low Oxygen Saturation
MAUDE report 7848546 ↗MalfunctionSep 5, 2018Improper Flow or Infusion; Improper Flow or Infusion
IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, A 980 VENTILATOR ENTERED INTO BACKUP VENTILATION. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR. THE PATIENT DESATURATED.
Patient problems: Low Oxygen Saturation
MAUDE report 7848520 ↗MalfunctionSep 5, 2018Improper Flow or Infusion; Improper Flow or Infusion
IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, A 980 VENTILATOR ENTERED INTO BACKUP VENTILATION. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND MANUALLY VENTILATED VIA AN AMBU BAG BEFORE BEING PLACED ON AN ALTERNATE VENTILATOR. THE PATIENT DESATURATED AND THEN RECOVERED TO THEIR NORMAL OXYGEN LEVEL.
Patient problems: Low Oxygen Saturation
MAUDE report 7847915 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page