Puritan Bennett 4-840220DRAC-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 10884521077171), received between Mar 30, 2017 and Jun 23, 2017 — classified as 5 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (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 Display/Image4
Erratic or Intermittent Display1

Patient problems

No Patient Involvement3
No Information2

Recent adverse event reports

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

MalfunctionJun 23, 2017Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS REPORTED THAT AN 840 VENTILATOR HAD AN ERRATIC LOWER DISPLAY. THE VENTILATOR WAS NOT ON A PATIENT AT THE TIME OF THE EVENT. THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND REPLACED THE GRAPHICAL USER INTERFACE (GUI) PRINTED CIRCUIT BOARD (PCB) AND UPDATED THE BACKLIGHT INVERTER PCBS. THE UNIT PASSED ALL TESTING AND OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS.
Patient problems: No Patient Involvement
MAUDE report 6663945 ↗
MalfunctionMay 8, 2017No Display/Image; No Display/Image
IT WAS REPORTED THAT AN 840 VENTILATOR HAD AN ERROR CODE, IT WAS REQUIRED TO CHANGE THE GUI CPU PCB. THE VENTILATOR WAS NOT ON A PATIENT AT THE TIME OF THE EVENT.
Patient problems: No Patient Involvement
MAUDE report 6551058 ↗
MalfunctionApr 25, 2017No Display/Image; No Display/Image
IT WAS REPORTED THAT, AN 840 VENTILATOR HAD A SOFTWARE UPDATE DUE TO A DEFECTIVE GRAPHICAL USER INTERFACE (GUI) PRINTED CIRCUIT BOARD (PCB). THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THE MALFUNCTION OCCURRED. THE SERVICE ENGINEER (SE) VERIFIED THE MALFUNCTION AND REPLACED THE GUI PCB. THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.
Patient problems: No Patient Involvement
MAUDE report 6518235 ↗
MalfunctionMar 31, 2017No Display/Image; No Display/Image
IT WAS REPORTED THAT, AN 840 VENTILATOR HAD A FAULTY DISPLAY. PATIENT INVOLVEMENT INFORMATION WAS NOT PROVIDED.
Patient problems: No Information
MAUDE report 6451062 ↗
MalfunctionMar 30, 2017No Display/Image; No Display/Image
IT WAS REPORTED THAT THE PB840 VENTILATOR HAS A DISPLAY ISSUE. PATIENT INVOLVEMENT WAS NOT PROVIDED. THE MEDTRONIC SERVICE ENGINEER (SE) EVALUATED THE VENTILATOR AND REPLACED THE GRAPHIC USER INTERFACE (GUI) CENTRAL PROCESSING UNIT (CPU) PRINTED CIRCUIT BOARD (PCB) AND THE BACKLIGHT INVERTER PCBS. THE VENTILATOR PASSED ALL TESTING AND WAS PLACED BACK IN USE AT THE CUSTOMER SITE.
Patient problems: No Information
MAUDE report 6447592 ↗

Device details

UDI-DI	`10884521077171`
Brand	Puritan Bennett
Model	4-840220DRAC-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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