Puritan Bennett 4-840220AIQC-FRRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10884521076983), received between Apr 17, 2017 and Jul 15, 2024 — classified as 13 malfunctions.

The most frequently reported specific device problem is “No Flow” (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

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2024Smoking; Smoking

  IT WAS REPORTED THAT THE 840 VENTILATOR EMITTED SMOKE FROM THE POWER SUPPLY WHEN TURNED ON. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19746824 ↗
• MalfunctionJun 27, 2024Smoking; Output Problem; Smoking; Output Problem

  ADDITONAL INFORMATION AS FOLLOWS: IT WAS REPORTED THAT DURING SERVICING, THE 840 VENTILATOR DID NOT PASS THE SHORT SELF TEST (SST). THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19627774 ↗
• MalfunctionJul 6, 2022No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS 840 VENTILATOR SHUT DOWN AND VENTILATION STOPPED. THE PATIENT WAS PLACED ON AN ALTERNATE VENTILATOR WITHOUT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14940432 ↗
• MalfunctionJan 12, 2022No Flow; Output Problem; No Flow; Output Problem

  IT WAS REPORTED THAT DURING PREVENTATIVE MAINTENANCE, THIS 840 VENTILATOR GENERATED A VISUAL AND SOUND ALARM WITH A BACKGROUND CHECKS GUI (GRAPHICAL USER INTERFACE) DIAGNOSTIC CODE. IT WAS ADDITIONALLY REPORTED THAT CONTINUOUS AUDIBLE ALARM, ¿TECHNICAL ALARM¿, VISUAL MESSAGE ¿VENT INOP¿, AND POST BDU (POWER ON SELF TEST, BREATH DELIVERY UNIT) DIAGNOSTIC CODE WERE GENERATED. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13238889 ↗
• MalfunctionMar 4, 2021No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS 840 VENTILATOR SHUTDOWN AND HAD A LOSS OF VENTILATION. THE VENTILATOR STOPPED V ENTILATING THE PATIENT. THE PATIENT WAS PLACED ON AN ALTERNATE VENTILATOR WITHOUT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11418206 ↗
• MalfunctionApr 27, 2018Power Problem; Power Problem

  IT WAS REPORTED THAT DURING SERVICING, THE 840 VENTILATOR HAD A POWER SUPPLY ISSUE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7470675 ↗
• MalfunctionOct 18, 2017Fire; Fire

  IT WAS REPORTED THAT PRIOR TO USE, THE 840 VENTILATOR HAD A BURNING SMELL WHEN TURNED ON. THERE WAS A PENETRATION OF LIQUID ONTO THE SCREEN. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6959370 ↗
• MalfunctionAug 10, 2017No Display/Image; No Display/Image

  IT WAS REPORTED THAT AN 840 VENTILATOR HAD A FROZEN DISPLAY. AT THIS TIME, IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. A SERVICE ENGINEER INSPECTED THE DEVICE AND WAS NOT ABLE TO DUPLICATE THE ISSUE. THE UNIT PASSED ALL TESTING AND OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 6787190 ↗
• MalfunctionAug 4, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT AN 840 VENTILATOR HAD A CONSTANT ALARM. NO PATIENT HARM OR INJURY REPORTED. ADDITIONAL DETAILS OF THE EVENT HAVE BEEN REQUESTED.

  Patient problems: No Information

  MAUDE report 6768061 ↗
• MalfunctionJun 8, 2017Low Readings; Low Readings

  IT WAS REPORTED THAT, AN 840 VENTILATOR WAS GIVING LOW OXYGEN READINGS. ALTHOUGH REQUESTED, INFORMATION REGARDING THE INTERVENTION TAKEN ON THE BEHALF OF THE PATIENT WAS NOT BEEN PROVIDED.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 6628905 ↗
• MalfunctionMay 30, 2017Device Inoperable; Device Inoperable

  IT WAS REPORTED THAT AN 840 VENTILATOR HAD AN ERROR CODE DT0002 DURING POST (POWER ON SELF TEST). THE VENTILATOR WAS NOT ON A PATIENT AT THE TIME OF THE EVENT. THE COVIDIEN SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND REPLACED THE BD PCBA (BREATH DELIVERY-PRINTED CIRCUIT BOARD) TO CORRECT THE ISSUE. THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 6598678 ↗
• MalfunctionApr 24, 2017Device Inoperable; Device Inoperable

  IT WAS REPORTED THAT AN, 840 VENTILATOR GENERATED ERROR CODES WHICH RENDERED THE VENTILATOR INOPERABLE. ALTHOUGH REQUESTED, INFORMATION PERTAINING TO THE USE OF THE DEVICE AT THE TIME OF THE REPORTED EVENT AND PATIENT OUTCOME (IF APPLICABLE) HAS NOT BEEN PROVIDED. THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND REPLACED THE BREATH DELIVERY UNIT (BDU) PRINTED CIRCUIT BOARD (PCB). THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Information

  MAUDE report 6515320 ↗
• MalfunctionApr 17, 2017Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE VENTILATOR GENERATED LOSS OF COMMUNICATION CODES. THE VENTILATOR WAS NOT ON A PATIENT AT THE TIME OF THE EVENT. THE SERVICE ENGINEER EVALUATED THE VENTILATOR AND REPLACED THE GRAPHIC USER INTERFACE (GUI) PRINTED CIRCUIT BOARD (PCB). THE VENTILATOR PASSED SELF-TESTING.

  Patient problems: No Patient Involvement

  MAUDE report 6497023 ↗