Puritan Bennett 4-840220AIQC-ENRecalls & reported problems

Covidien LP · 800 Series Ventilator System,Model 840 · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 5
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521076976), received between Jun 14, 2017 and Sep 26, 2018 — classified as 5 malfunctions.

The most frequently reported specific device problem is “No Flow” (4 reports).

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.

Most reported problems

Device problems

No Flow4
Appropriate Device Problem Term/Code Not Available1
No Display/Image1

Patient problems

No Consequences Or Impact To Patient4
No Code Available3
No Patient Involvement1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 26, 2018No Flow; Appropriate Device Problem Term/Code Not Available; No Flow; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE 840 VENTILATOR STOPPED VENTILATION AND THE SYSTEMS LOCKED OUT. THERE WAS NO INJURY TO THE PATIENT AS A RESULT OF THE EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7912672 ↗
MalfunctionSep 26, 2018No Flow; No Flow
IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE 840 VENTILATOR STOPPED VENTILATION AND THE SYSTEMS WERE LOCKED OUT. THERE WAS NO INJURY TO THE PATIENT AS A RESULT OF THE EVENT.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 7912648 ↗
MalfunctionSep 26, 2018No Flow; No Flow
IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE 840 VENTILATOR STOPPED VENTILATION AND THE SYSTEMS WERE LOCKED OUT. THERE WAS NO INJURY TO THE PATIENT AS A RESULT OF THE EVENT.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 7910550 ↗
MalfunctionSep 26, 2018No Flow; No Flow
IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE 840 VENTILATOR STOPPED VENTILATION AND THE SYSTEMS WERE LOCKED OUT. THERE WAS NO INJURY TO THE PATIENT AS A RESULT OF THE EVENT.
Patient problems: No Code Available; No Consequences Or Impact To Patient
MAUDE report 7910518 ↗
MalfunctionJun 14, 2017No Display/Image; No Display/Image
IT WAS REPORTED THAT AN 840 VENTILATOR HAD A FAULTY DISPLAY. THE VENTILATOR WAS NOT ON A PATIENT AT THE TIME OF THE EVENT. THE SERVICE ENGINEER REPLACED THE BACKLIGHT INVERTER BOARD, THE GUI (GRAPHICAL USER INTERFACE) BOARD AND DOWNLOADED SOFTWARE TO CORRECT THE ISSUE. THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.
Patient problems: No Patient Involvement
MAUDE report 6642042 ↗

Device details

UDI-DI	`10884521076976`
Brand	Puritan Bennett
Model	4-840220AIQC-EN
Company	Covidien LP
Product code	CBK · VENTILATOR, CONTINUOUS, FACILITY USE
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jun 24, 2025

Device type (GMDN): Neonatal/adult intensive-care ventilator

A mains electricity (AC-powered) automatic cycling device intended to provide long-term alveolar ventilation support for the full age-range of patients, from neonatal, paediatric to adult, in a critical care setting. It typically uses positive pressure to deliver gas at normal breathing rates and tidal volumes through an endotracheal (ET) tube or tracheostomy, and consists of a breathing circuit, a control system, monitors, and alarms. The inhalation limb includes sites where inspired gas may be heated/humidified, and the exhalation limb includes an exhaust valve to release gas to the ambient air. It can be operated in several modes (e.g., assist/control, synchronized, patient triggered).

Other VENTILATOR, CONTINUOUS, FACILITY USE devices

Trilogy Trilogy100 Ventilator, United States
Respironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE
92 deaths8,161 reports
Trilogy Evo Trilogy Evo, USA
Respironics, Inc. · Ventilator, continuous, facility use
6 recalls50 deaths4,393 reports
Trilogy 100 Trilogy 100 W/ Bluetooth, USA
Respironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE
65 deaths4,569 reports
CARESCAPE R860
Datex-Ohmeda Inc · VENTILATOR, CONTINUOUS, FACILITY USE
1 recall1 death4,346 reports
HAMILTON-C1 161001
Hamilton Medical AG · Ventilator, Continuous, Facility Use
2 recalls12 deaths1,849 reports
Trilogy Trilogy O2 Ventilator Japan
Respironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE
7 deaths1,900 reports
Trilogy Trilogy 202 Ventilator International
Respironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE
11 deaths1,564 reports
HAMILTON-C6 160021
Hamilton Medical AG · Ventilator, Continuous, Facility Use
5 recalls10 deaths1,175 reports

All VENTILATOR, CONTINUOUS, FACILITY USE devices →

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
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