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Puritan Bennett 980S1ESDIUURecalls & 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

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
2

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521201248), received between May 4, 2018 and Feb 10, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Inoperable” (1 report).

2 FDA recall records name this device's identifier, 2 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

  1. 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 ↗

  2. Oct 16, 2020Class IIOpen, Classified

    In-house lab observations and customer reports of overheating and/or thermal damage to the battery pack, create the risk of exposure to smoke or hazardous materials, which may result in burns and/or bronchospasm,

    Z-0425-2021 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Device problems

  • Device Inoperable1
  • Smoking1

Patient problems

  • No Consequences Or Impact To Patient1
  • No Information1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 10, 2020Smoking; Smoking

    IT WAS REPORTED THAT, WHILE IN USE ON A PREMATURE NEONATE PATIENT ((B)(6) WEEKS), A 980 VENTILATOR IN CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) MODE WAS OBSERVED TO HAVE SMOKE COMING FROM THE VENTILATOR. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO HARM OR INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9689358 ↗
  • MalfunctionMay 4, 2018Device Inoperable; Device Inoperable

    IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, A 980 VENTILATOR GENERATED A ¿VENTILATOR INOPERATIVE¿ ALARM. 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 Information

    MAUDE report 7489056 ↗

Other VENTILATOR, CONTINUOUS, FACILITY USE devices

All VENTILATOR, CONTINUOUS, FACILITY USE devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page