Puritan Bennett 4-840220DIEC-ITRecalls & reported problems
Covidien LP · 800 Series Ventilator System,Model 840 · Class 2
All models of Puritan Bennett (119)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Covidien Puritan Bennett ventilator provides continuous breathing support in healthcare facilities. The 35 reports mostly describe displays that were blank, red, or showing errors, along with problems involving power, oxygen sensing, and calibration. There were no deaths or injuries reported, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 35
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10884521077034), received between Mar 15, 2017 and Feb 1, 2019 — classified as 35 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (12 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/Image12
- Device Inoperable4
- Device Displays Incorrect Message3
- Erratic or Intermittent Display3
- Failure to Calibrate2
- Occlusion Within Device2
- Calibration Problem1
- Device Alarm System1
Patient problems
- No Patient Involvement35
- No Information2
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 1, 2019No Flow; No Flow
IT WAS REPORTED THAT DURING ROUTINE SERVICE AND REPAIR, THE 840 VENTILATOR DID NOT PASS THE POWER ON SELF-TEST (POST) WITH AN AIR PROPORTIONAL SOLENOID (PSOL) STUCK OPEN ERROR CODE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT.
Patient problems: No Patient Involvement
MAUDE report 8299442 ↗MalfunctionOct 18, 2017Fire; Fire
IT WAS REPORTED THAT THE 840 VENTILATOR HAD A BURNT POWER SUPPLY. AT THIS TIME, IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT.
Patient problems: No Information; No Patient Involvement
MAUDE report 6959801 ↗MalfunctionAug 28, 2017No Display/Image; No Display/Image
IT WAS REPORTED THAT AN 840 VENTILATOR HAD A COMPLETELY RED DISPLAY. AT THIS TIME, IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. A 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 Information; No Patient Involvement
MAUDE report 6825335 ↗MalfunctionAug 16, 2017Device Sensing Problem; Device Sensing Problem
IT WAS REPORTED THAT AN 840 VENTILATOR'S TOUCH DISPLAY WAS NOT WORKING. THE VENTILATOR WAS NOT ON A PATIENT AT THE TIME OF THE EVENT. A SERVICE ENGINEER INSPECTED THE DEVICE AND REPLACED THE TOUCHSCREEN PRINTED CIRCUIT BOARD. THE UNIT PASSED ALL TESTING AND OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS.
Patient problems: No Patient Involvement
MAUDE report 6799133 ↗MalfunctionAug 11, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT AN 840 VENTILATOR HAD AN OXYGEN SENSOR ISSUE. THE VENTILATOR WAS NOT ON A PATIENT AT THE TIME OF THE EVENT. THE SERVICE ENGINEER REPLACED THE OXYGEN SENSOR TO CORRECT THE ISSUE. THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.
Patient problems: No Patient Involvement
MAUDE report 6788609 ↗MalfunctionAug 8, 2017Device Displays Incorrect Message; Device Displays Incorrect Message
IT WAS REPORTED THAT AN 840 VENTILATOR HAD A KEYBOARD WHICH GENERATED AN ERROR CODE. THE VENTILATOR WAS NOT ON A PATIENT AT THE TIME OF THE EVENT. A SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND REPLACED THE KEYBOARD TO ADDRESS THE ISSUE. THE UNIT PASSED ALL TESTING AND OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS.
Patient problems: No Patient Involvement
MAUDE report 6774667 ↗MalfunctionAug 2, 2017No Display/Image; No Display/Image
IT WAS REPORTED THAT AN 840 VENTILATOR HAD A FAULTY DISPLAY; THE UPPER DISPLAY DID NOT WORK. THE VENTILATOR WAS NOT ON A PATIENT AT THE TIME OF THE EVENT. THE SERVICE ENGINEER REPLACED THE GRAPHICAL USER INTERFACE (GUI) FLEX CABLE TO ADDRESS THE ISSUE. THE UNIT PASSED ALL TESTING AND OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS.
Patient problems: No Patient Involvement
MAUDE report 6760806 ↗MalfunctionAug 1, 2017Failure to Calibrate; Failure to Calibrate
IT WAS REPORTED THAT, AN 840 VENTILATOR HAD AN OXYGEN SENSOR MALFUNCTION. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THE EVENT OCCURRED. THE COVIDIEN SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND REPLACED THE OXYGEN SENSOR. THE UNIT PASSED ALL TESTING AND OPERATED WITHIN THE MANUFACTURER SPECIFICATIONS.
Patient problems: No Patient Involvement
MAUDE report 6758834 ↗MalfunctionAug 1, 2017Occlusion Within Device; Occlusion Within Device
IT WAS REPORTED THAT, AN 840 VENTILATOR HAD AN OCCLUSION ALARM. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THE EVENT OCCURRED. THE COVIDIEN TECH SUPPORT ENGINEER (TSE) TROUBLESHOT THIS ISSUE WITH THE CUSTOMER OVER THE PHONE AND RECOMMENDED REPLACING INSPIRATORY FILTER. THE CUSTOMER FOLLOWED THE TSE RECOMMENDATIONS AND THE INSPIRATORY FILTER WAS REPLACED. THE UNIT PASSED ALL TESTING AND OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS. COVIDIEN WAS NOT AUTHORIZED TO SERVICE THE DEVICE.
Patient problems: No Patient Involvement
MAUDE report 6758491 ↗MalfunctionJul 28, 2017No Display/Image; No Display/Image
IT WAS REPORTED AN 840 VENTILATOR HAD A BLANK UPPER DISPLAY. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE REPORTED INCIDENT. THE SERVICE ENGINEER REPLACED THE BACKLIGHT ASSEMBLY. THE VENTILATOR WAS IN WORKING CONDITION.
Patient problems: No Patient Involvement
MAUDE report 6751871 ↗MalfunctionJul 28, 2017No Display/Image; No Display/Image
IT WAS REPORTED THAT, AN 840 VENTILATOR HAD THE UPPER DISPLAY BLANK. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THE EVENT OCCURRED. THE SERVICE ENGINEER (SE) REPLACED THE GRAPHICAL USER INTERFACE (GUI) PRINTED CIRCUIT BOARD (PCB). THE UNIT PASSED ALL TESTING AND OPERATED WITHIN THE MANUFACTURER SPECIFICATIONS. IN THE EVENT THE DEVICE IS RECEIVED FOR EVALUATION OR ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SUBMITTED.
Patient problems: No Patient Involvement
MAUDE report 6750730 ↗MalfunctionJul 27, 2017Electrical Power Problem; Electrical Power Problem
IT WAS REPORTED THAT, AN 840 VENT WAS FUNCTIONING ON ALTERNATING CURRENT (AC). THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THE EVENT OCCURRED. THE COVIDIEN SERVICE ENGINEER (SE) VERIFIED THE ISSUE AND REPLACED THE POWER SUPPLY. THE UNIT PASSED ALL TESTING AND OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS.
Patient problems: No Patient Involvement
MAUDE report 6747547 ↗MalfunctionJul 27, 2017Occlusion Within Device; Occlusion Within Device
IT WAS REPORTED THAT, AN 840 VENT HAD A SEVERE OCCLUSION ALARM. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THE EVENT OCCURRED. THE COVIDIEN SERVICE ENGINEER (SE) VERIFIED THE ISSUE. THE SE INSPECTED THE DEVICE AND REPLACED THE ANALOG INTERFACE (AI) PRINTED CIRCUIT BOARD (PCB). THE UNIT PASSED ALL TESTING AND OPERATED WITHIN THE MANUFACTURES SPECIFICATIONS.
Patient problems: No Patient Involvement
MAUDE report 6747489 ↗MalfunctionJul 25, 2017No Display/Image; No Display/Image
IT WAS REPORTED THAT AN 840 VENTILATOR'S DISPLAY WOULD NOT TURN ON. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE REPORTED INCIDENT. THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND RESOLVED THE ISSUE BY CLEANING THE ELECTRICAL CONTACTS. NO PARTS WERE REPLACED. THE UNIT PASSED ALL TESTING AND OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS.
Patient problems: No Patient Involvement
MAUDE report 6741024 ↗MalfunctionJul 19, 2017No Display/Image; No Display/Image
IT WAS REPORTED AN 840 VENTILATOR HAD A FAULTY DISPLAY SCREEN. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE REPORTED INCIDENT. THE SERVICE ENGINEER INSPECTED THE DEVICE AND REPLACED THE GUI (GRAPHICAL USER INTERFACE) PCB (PRINTED CIRCUIT BOARD). THE UNIT PASSED ALL TESTING AND OPERATED WITHIN THE MANUFACTURER'S SPECIFICATIONS.
Patient problems: No Patient Involvement
MAUDE report 6725482 ↗MalfunctionJun 28, 2017Device Inoperable; Device Inoperable
IT WAS REPORTED THAT AN 840 VENTILATOR COMPRESSOR DID NOT START. THE VENTILATOR WAS NOT ON A PATIENT AT THE TIME OF THE EVENT. THE SERVICE ENGINEER INSPECTED THE DEVICE AND REPLACED A FUSE TO ADDRESS THE ISSUE. THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.
Patient problems: No Patient Involvement
MAUDE report 6673857 ↗MalfunctionJun 26, 2017No Display/Image; No Display/Image
IT WAS REPORTED BY COVIDIEN SERVICE ENGINEER (SE) THAT DURING THE PREVENTIVE MAINTENANCE OF THE 840 VENTILATOR THE DISPLAY WAS FOUND FAULTY. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THE MALFUNCTION OCCURRED. THE SE REPLACED THE GRAPHICAL USER INTERFACE (GUI) PRINTED CIRCUIT BOARD (PCB), THE BACKLIGHT INVERTER PCB¿S WERE UPGRADED AND THE LATEST VERSION OF THE OPERATIONAL SOFTWARE WAS INSTALLED. THE UNIT PASSED ALL TESTING AND OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS.
Patient problems: No Patient Involvement
MAUDE report 6666601 ↗MalfunctionJun 15, 2017Device Inoperable; Device Inoperable
IT WAS REPORTED THAT THE VENTILATOR GENERATED AN ERROR MESSAGE WHICH RENDERED THE GRAPHICAL USER INTERFACE (GUI) PRINTED CIRCUIT BOARD (PCB). THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT OCCURRED. THE SERVICE ENGINEER INSPECTED THE DEVICE AND REPLACED THE GUI PCB. THE VENTILATOR PASSED ALL TESTS AND OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS.
Patient problems: No Patient Involvement
MAUDE report 6645756 ↗MalfunctionJun 1, 2017Failure to Power Up; Failure to Power Up
IT WAS REPORTED THAT AN 840 VENTILATOR HAD A POWER SUPPLY ISSUE. 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 6606382 ↗MalfunctionMay 22, 2017No Display/Image; No Display/Image
IT WAS REPORTED THAT AN 840 VENTILATOR HAD A BLANK DISPLAY. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE REPORTED EVENT. A SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND CONFIRMED THE REPORTED CONDITION. TO ADDRESS THE ISSUE, THE SE REPLACED THE GRAPHICAL USER INTERFACE (GUI) PRINTED CIRCUIT BOARD (PCB), BACKLIGHT INVERTER PCBS, LIQUID CRYSTAL DISPLAY (LCD PANELS), AND SCREENS. THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.
Patient problems: No Patient Involvement
MAUDE report 6583165 ↗MalfunctionMay 18, 2017No Display/Image; No Display/Image
IT WAS REPORTED THAT AN 840 VENTILATOR HAD A BLANK DISPLAY. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED E VENT. A SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND THE GRAPHICAL USER INTERFACE (GUI) PRINTED CIRCUIT BOARD (PCB) WAS REPLACED THE BACKLIGHT INVERTER PCBS WERE UPDATED. THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.
Patient problems: No Patient Involvement
MAUDE report 6575201 ↗MalfunctionMay 16, 2017Device Inoperable; Device Inoperable
IT WAS REPORTED THAT AN 840 VENTILATOR BECAME INOPERABLE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT. A SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND REPLACED THE BREATH DELIVERY (BD) CENTRAL PROCESSING UNIT (CPU) PRINTED CIRCUIT BOARD (PCB). THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.
Patient problems: No Patient Involvement
MAUDE report 6570994 ↗MalfunctionMay 16, 2017Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS REPORTED THAT AN 840 VENTILATOR HAD A LOW DISPLAY ISSUE. THE VENTILATOR WAS NOT ON A PATIENT AT THE TIME OF THE EVENT. THE SERVICE ENGINEER REPAIRED THE VENTILATOR BY REPLACING THE : GRAPHICAL USER INTERFACE (GUI) PRINTED CIRCUIT BOARD (PCB) RAN ELECTRIC SAFETY VERIFICATIONS AND ALL TESTS PASSED SUCCESSFULLY.
Patient problems: No Patient Involvement
MAUDE report 6570697 ↗MalfunctionMay 16, 2017Device Displays Incorrect Message; Device Displays Incorrect Message
IT WAS REPORTED THAT AN 840 VENTILATOR HAD A KEYBOARD ISSUE. THE VENTILATOR WAS NOT ON A PATIENT AT THE TIME OF THE EVENT. THE SERVICE ENGINEER REPAIRED THE VENTILATOR, REPLACED THE FLOW SENSOR AND THE KEYBOARD AND RAN PERFORMANCE TESTS SUCCESSFULLY.
Patient problems: No Patient Involvement
MAUDE report 6570688 ↗MalfunctionMay 8, 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.
Patient problems: No Patient Involvement
MAUDE report 6553203 ↗
Other VENTILATOR, CONTINUOUS, FACILITY USE devices
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- CARESCAPE R860Datex-Ohmeda Inc · VENTILATOR, CONTINUOUS, FACILITY USE1 recall1 death4,346 reports
- HAMILTON-C1 161001Hamilton Medical AG · Ventilator, Continuous, Facility Use2 recalls12 deaths1,849 reports
- Trilogy Trilogy O2 Ventilator JapanRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE7 deaths1,900 reports
- Trilogy Trilogy 202 Ventilator InternationalRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE11 deaths1,564 reports
- HAMILTON-C6 160021Hamilton Medical AG · Ventilator, Continuous, Facility Use5 recalls10 deaths1,175 reports
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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