Skip to content

Puritan Bennett 980X3PLDIPCRecalls & 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

2 open recalls name 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
2

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521172593), received between May 24, 2017 and Aug 15, 2017 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (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

  • Appropriate Device Problem Term/Code Not Available2
  • Battery Problem1
  • Device Displays Incorrect Message1
  • Device Inoperable1
  • Insufficient Device Problem Information1

Patient problems

  • No Patient Involvement6
  • No Information4

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 15, 2017Device Inoperable; Device Inoperable

    IT WAS REPORTED THAT THE COMPRESSOR ON A 980 VENTILATOR WAS INOPERATIVE. ALTHOUGH REQUESTED, IT IS UNKNOWN IF THE PATIENT WAS CONNECTED TO THE VENTILATOR AT THE TIME OF THE REPORTED EVENT. THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND FOUND A DIAGNOSTIC CODE IN THE VENTILATOR'S MEMORY LOGS. THE SE CLEANED THE "ELECTRICAL CONTACTORS OF THE COMPILER". THE SE PERFORMED CALIBRATIONS AND EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED.

    Patient problems: No Information; No Patient Involvement

    MAUDE report 6795372 ↗
  • MalfunctionAug 15, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT A 980 VENTILATOR HAD AN OXYGEN (O2) SENSOR ISSUE. ALTHOUGH REQUESTED, IT IS UNKNOWN IF THE PATIENT WAS CONNECTED TO THE VENTILATOR AT THE TIME OF THE REPORTED EVENT. THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND REPLACED THE O2 SENSOR. THE SE PERFORMED CALIBRATIONS AND EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED.

    Patient problems: No Information; No Patient Involvement

    MAUDE report 6794743 ↗
  • MalfunctionJul 11, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED THAT THE OXYGEN (O2) SENSOR OF A 980 VENTILATOR EXPERIENCED A MALFUNCTION. ALTHOUGH REQUESTED, IT IS UNKNOWN IF THE PATIENT WAS CONNECTED TO THE VENTILATOR AT THE TIME OF THE REPORTED EVENT. THE SERVICE ENGINEER (SE) REPLACED THE O2 SENSOR.

    Patient problems: No Information; No Patient Involvement

    MAUDE report 6704505 ↗
  • MalfunctionJun 12, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

    IT WAS REPORTED THAT A 980 VENTILATOR GENERATED AN ERROR MESSAGE. ALTHOUGH REQUESTED, IT IS UNKNOWN IF THE PATIENT WAS CONNECTED TO THE VENTILATOR AT THE TIME OF THE REPORTED EVENT. THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND FOUND DIAGNOSTIC CODES IN THE VENTILATORS MEMORY LOGS. THE SE INSTALLED A NEW VERSION OF SOFTWARE. THE SE PERFORMED CALIBRATIONS AND EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED.

    Patient problems: No Information; No Patient Involvement

    MAUDE report 6634976 ↗
  • MalfunctionMay 24, 2017Battery Problem; Battery Problem

    IT WAS REPORTED THAT A 980 VENTILATOR BATTERY FAILED. 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 REPLACED THE BATTERY. THE SE PERFORMED CALIBRATIONS AND EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED.

    Patient problems: No Patient Involvement

    MAUDE report 6588591 ↗
  • MalfunctionMay 24, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED THAT A 980 VENTILATOR HAD AN OXYGEN (O2) SENSOR FAILURE. 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 REPLACED THE O2 SENSOR. THE SE PERFORMED CALIBRATIONS AND EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED.

    Patient problems: No Patient Involvement

    MAUDE report 6588422 ↗

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