Puritan Bennett 4-840220DIJI-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: 7
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521077065), received between May 24, 2017 and Aug 10, 2017 — classified as 7 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (3 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 Display/Image3
Battery Problem2
Device Inoperable1
Insufficient Device Problem Information1

Patient problems

No Patient Involvement7
No Information1

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

MalfunctionAug 10, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED AN 840 VENTILATOR HAD A FAULTY OXYGEN SENSOR. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE REPORTED INCIDENT. THE SERVICE ENGINEER CLEANED AND CALIBRATED THE EXPIRATORY VALVE.
Patient problems: No Patient Involvement
MAUDE report 6784567 ↗
MalfunctionAug 7, 2017Battery Problem; Battery Problem
IT WAS REPORTED THAT AN 840 VENTILATOR HAD A BACKUP BATTERY FAILURE. THE VENTILATOR WAS NOT ON A PATIENT AT THE TIME OF THE EVENT. THE SERVICE ENGINEER REPLACED THE BACKUP BATTERY TO CORRECT THE ISSUE. THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.
Patient problems: No Patient Involvement
MAUDE report 6771388 ↗
MalfunctionJun 27, 2017No Display/Image; No Display/Image
IT WAS REPORTED AN 840 VENTILATOR HAD A FAULTY DISPLAY. AT THIS TIME, PATIENT INVOLVEMENT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Information; No Patient Involvement
MAUDE report 6669699 ↗
MalfunctionJun 12, 2017Battery Problem; Battery Problem
IT WAS REPORTED THAT AN 840 VENTILATOR HAD A BATTERY THAT DISCHARGED QUICKLY. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT. A SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND REPLACED THE BATTERY. THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.
Patient problems: No Patient Involvement
MAUDE report 6633637 ↗
MalfunctionJun 6, 2017No Display/Image; No Display/Image
IT WAS REPORTED THAT THE 840 VENTILATOR HAD A FAULTY DISPLAY. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT.
Patient problems: No Patient Involvement
MAUDE report 6613893 ↗
MalfunctionJun 1, 2017Device Inoperable; Device Inoperable
THE EVALUATION AND REPAIR OF THE DEVICE HAS BEEN COMPLETED.
Patient problems: No Patient Involvement
MAUDE report 6606254 ↗
MalfunctionMay 24, 2017No Display/Image; No Display/Image
IT WAS REPORTED THAT THE 840 VENTILATOR HAD A GUI PCB (GRAPHICAL USER INTERFACE PRINTER CIRCUIT BOARD) ERROR. THE VENTILATOR WAS NOT ON A PATIENT AT THE TIME OF THE EVENT. THE EVALUATION AND REPAIR OF THE DEVICE HAS NOT BEEN COMPLETED.
Patient problems: No Patient Involvement
MAUDE report 6587845 ↗

Device details

UDI-DI	`10884521077065`
Brand	Puritan Bennett
Model	4-840220DIJI-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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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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