Puritan Bennett 4-840220NISC-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: 3
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521077218), received between Mar 29, 2017 and Jul 13, 2020 — classified as 3 malfunctions.

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

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

Insufficient Device Problem Information1
No Display/Image1
No Flow1

Patient problems

No Patient Involvement2
High Blood Pressure/ Hypertension1
Low Blood Pressure/ Hypotension1
No Information1
Tachycardia1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

MalfunctionJul 13, 2020No Flow; No Flow
IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, AN 840 VENTILATOR GENERATED A HIGH VOLUME ALARM, RED SCREEN AND THE UNIT STOPPED VENTILATING THE PATIENT. AFTER THE VENTILATOR WAS REBOOTED, IT WAS STILL NOT WORKING. THE PATIENT WAS REMOVED FROM THE VENTILATOR, MANUALLY VENTILATED AND PLACED ON AN ALTERNATE VENTILATOR. THE PATIENT EXPERIENCED TACHYCARDIA (90 BEATS PER MINUTE), HYPERTENSION FOLLOWED BY HYPOTENSION WHICH WAS TREATED WITH NORADRENALINE. THE PATIENT RETURNED TO BASELINE WITHIN 30 MINUTES.
Patient problems: High Blood Pressure/ Hypertension; Low Blood Pressure/ Hypotension; Tachycardia
MAUDE report 10268179 ↗
MalfunctionAug 1, 2017No Display/Image; No Display/Image
IT WAS REPORTED THAT, AN 840 VENTILATOR HAD A BLANK THE UPPER DISPLAY. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THE EVENT OCCURRED. THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND REPLACED THE POWER SUPPLY TO CORRECT THE ISSUE. THE UNIT PASSED ALL TESTING AND OPERATED WITHIN THE MANUFACTURER SPECIFICATIONS.
Patient problems: No Patient Involvement
MAUDE report 6758930 ↗
MalfunctionMar 29, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT, AN 840 VENTILATOR HAD A BATTERY ISSUE. INFORMATION ABOUT PATIENT INVOLVEMENT WAS NOT PROVIDED. THE SERVICE ENGINEER (SE) EVALUATED THE VENTILATOR AND VERIFIED THE CUSTOMER REPORTED ISSUE. THE SE REPLACED THE BATTERY AND UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.
Patient problems: No Information; No Patient Involvement
MAUDE report 6444875 ↗

Device details

UDI-DI	`10884521077218`
Brand	Puritan Bennett
Model	4-840220NISC-EN
Company	Covidien LP
Product code	CBK · VENTILATOR, CONTINUOUS, FACILITY USE
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	OTC
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	Not 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).

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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.

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