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Puritan Bennett 980X1ENASAARecalls & reported problems

Covidien LP · 980 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
3
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521171565), received between May 30, 2017 and May 3, 2018 — classified as 3 malfunctions.

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

  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 ↗

Most reported problems

Device problems

  • Device Displays Incorrect Message1
  • Device Inoperable1
  • No Display/Image1

Patient problems

  • No Patient Involvement2
  • 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.

  • MalfunctionMay 3, 2018Device Inoperable; Device Inoperable

    IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, A 980 VENTILATOR SHUT DOWN. 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 7485637 ↗
  • MalfunctionAug 8, 2017No Display/Image; No Display/Image

    IT WAS REPORTED THAT THE DISPLAY ON A 980 VENTILATOR WAS "FLICKERING INTERMITTENTLY" AND "FAULTY". THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT. A SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND CONFIRMED THE REPORTED ISSUE. TO ADDRESS THE ISSUE, THE VENTILATOR WAS REPLACED FOR ANOTHER PER CUSTOMER REQUEST.

    Patient problems: No Patient Involvement

    MAUDE report 6774267 ↗
  • MalfunctionMay 30, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

    IT WAS REPORTED THAT, WHEN A 980 VENTILATOR WAS POWERED ON, IT FAILED THE POWER ON SELF TEST (POST) AND GENERATED AN EXHALATION FLOW SENSOR 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 FOUND THE EXHALATION FLOW SENSOR WAS DAMAGED. THE SE REPLACED THE EXHALATION FLOW SENSOR AND PERFORMED EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED.

    Patient problems: No Patient Involvement

    MAUDE report 6598505 ↗

Other VENTILATOR, CONTINUOUS, FACILITY USE devices

All VENTILATOR, CONTINUOUS, FACILITY USE devices →

Sources and updates

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