Puritan Bennett 4-840220DIPC-PLRecalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10884521077096), received between Apr 14, 2017 and Jul 17, 2025 — classified as 1 injury, 29 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (8 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2025Smoking; Smoking

  IT WAS REPORTED THAT THIS 840 VENTILATOR HAD A POWER SUPPLY ISSUE, BURNING SMELL AND EMITTED SMOKE. 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 22533004 ↗
• MalfunctionMay 13, 2019Fire; Fire

  IT WAS REPORTED THAT DURING PATIENT USE, THE PB840 VENTILATOR COMPRESSOR PHYSICALLY BURNT. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITHOUT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8605390 ↗
• MalfunctionSep 17, 2018No Flow; No Flow

  IT WAS REPORTED THAT THE 840 VENTILATOR WAS NOT VENTILATING THE PATIENT. AT THIS TIME IT IS UNKNOWN IF THE PATIENT WAS TRANSFERRED OR IF THERE WAS HARM TO THE PATIENT AS A RESULT OF THE EVENT.

  Patient problems: No Information

  MAUDE report 7883144 ↗
• MalfunctionAug 23, 2018No Flow; No Flow

  IT WAS REPORTED THAT DURING USE, 840 VENTILATOR LACKED PATIENT VENTILATION AND DID NOT PROVIDE VOLUME. AT THIS TIME, IT IS UNKNOWN IF THE PATIENT WAS TRANSFERRED TO AN ALTERNATE VENTILATOR OR IF THERE WAS PATIENT HARM.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 7811681 ↗
• MalfunctionFeb 13, 2018Failure to Calibrate; Failure to Calibrate

  IT WAS REPORTED THAT DURING THE PREVENTATIVE MAINTENANCE SERVICE, THE 840 VENTILATOR FAILED THE FLOW SENSOR CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7267938 ↗
• MalfunctionAug 28, 2017Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT AN 840 VENTILATOR HAD AN UNRESPONSIVE RESET ALARM KEY ON THE KEYBOARD. 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 KEYBOARD ASSEMBLY. THE UNIT PASSED ALL TESTING AND OPERATED WITHIN THE MANUFACTURER SPECIFICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 6824222 ↗
• MalfunctionAug 28, 2017Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT AN 840 VENTILATOR HAD AN UNRESPONSIVE RESET KEY ALARM ON THE KEYBOARD. 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 KEYBOARD ASSEMBLY. THE UNIT PASSED ALL TESTING AND OPERATED WITHIN THE MANUFACTURER SPECIFICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 6823981 ↗
• MalfunctionAug 25, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED AN 840 VENTILATOR HAD A FAULTY OXYGEN SENSOR. ALTHOUGH REQUESTED, IT IS UNKNOWN IF THE PATIENT WAS CONNECTED TO THE VENTILATOR AT THE TIME OF THE REPORTED EVENT. THE SERVICE ENGINEER REPLACED THE OXYGEN SENSOR PERFORMED TESTING AND CALIBRATIONS AND THE VENTILATOR IS IN GOOD WORKING CONDITION.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 6822650 ↗
• MalfunctionAug 17, 2017No Display/Image; No Display/Image

  IT WAS REPORTED THAT AN 840 VENTILATOR HAD AN UNSPECIFIED GRAPHICAL USER INTERFACE (GUI) ISSUE. THE VENTILATOR WAS NOT ON A PATIENT AT THE TIME OF THE EVENT. THE SERVICE ENGINEER REPLACED THE 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 6801248 ↗
• MalfunctionJul 28, 2017Device Inoperable; Device Displays Incorrect Message; Device Inoperable; Device Displays Incorrect Message

  IT WAS REPORTED THAT AN 840 VENTILATOR GENERATED ERROR CODES WHICH RENDERED THE VENTILATOR IN AN INOPERABLE CONDITION AND BREATH DELIVERY (BD) POWER ON SELF-TEST (POST) FAILURE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THE EVENT OCCURRED. THE SERVICE ENGINEER (SE) REPLACED THE BREATH DELIVERY UNIT (BDU) PRINTED CIRCUIT BOARD (PCB) AND UPGRADED THE SOFTWARE TO THE LATEST VERSION. 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 6750901 ↗
• MalfunctionJul 28, 2017Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT AN 840 VENTILATOR HAD A LOSS OF GRAPHICAL USER INTERFACE (GUI) COMMUNICATION ERROR. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THE EVENT OCCURRED. THE SERVICE ENGINEER (SE) REPLACED THE GRAPHICAL UNIT INTERFACE (GUI) PRINTED CIRCUIT BOARD (PCB) AND UPGRADED THE BACKLIGHT PCBS. THE UNIT PASSED ALL TESTING AND OPERATED WITHIN THE MANUFACTURING 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 6750768 ↗
• MalfunctionJul 12, 2017No Display/Image; No Display/Image

  IT WAS REPORTED THAT, AN 840 VENTILATOR HAD A FAULTY DISPLAY. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THE EVENT OCCURRED. THE SERVICE ENGINEER (SE) VERIFIED THE ISSUE AND REPLACED THE GRAPHICAL USER INTERFACE (GUI) PRINTED CIRCUIT BOARD (PCB) AND THE BACKLIGHT INVERTER PCB'S WERE UPDATED. THE LATEST VERSION OF THE OPERATIONAL SOFTWARE WERE INSTALLED. THE UNIT PASSED ALL TESTING AND OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 6707510 ↗
• MalfunctionJun 28, 2017Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT AN 840 VENTILATOR HAD A TOUCHSCREEN ISSUE. AT THIS TIME, IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. A SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND CLEANED THE TOUCHSCREEN. THE UNIT PASSED ALL TESTING AND OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Information; No Patient Involvement

  MAUDE report 6674442 ↗
• MalfunctionJun 13, 2017Defective Component; Defective Component

  IT WAS REPORTED THAT AN 840 VENTILATOR HAD A GUI (GRAPHICAL USER INTERFACE) LATCH ISSUE. THE VENTILATOR WAS NOT ON A PATIENT AT THE TIME OF THE EVENT. THE SERVICE ENGINEER REPLACED THE GUI MONITOR LATCH TO CORRECT THE ISSUE. THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 6636891 ↗
• MalfunctionJun 12, 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. THE SERVICE ENGINEER REPLACED THE GUI (GRAPHICAL USER INTERFACE) BOARD AND LOADED THE SOFTWARE TO CORRECT THE ISSUE. THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 6635732 ↗
• MalfunctionJun 12, 2017Device Inoperable; Device Inoperable

  IT WAS REPORTED THAT AN 840 VENTILATOR HAD A GUI (GRAPHICAL USER INTERFACE) TOUCH FRAME ISSUE. PATIENT INVOLVEMENT IS UNKNOWN. THE SERVICE ENGINEER REPLACED THE BREATH DELIVERY UNIT BOARD AND THE GUI MONITOR LOCK TO CORRECT THE ISSUE. THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Information

  MAUDE report 6635670 ↗
• MalfunctionJun 12, 2017Device Inoperable; Device Inoperable

  IT WAS REPORTED THAT AN 840 VENTILATOR DID NOT PASS POST (POWER ON SELF TEST). THE VENTILATOR WAS NOT ON A PATIENT AT THE TIME OF THE EVENT. THE SERVICE ENGINEER REPLACED THE GUI (GRAPHICAL USER INTERFACE) MONITOR LOCK AND THE BDU (BREATH DELIVERY UNIT) BOARD TO CORRECT THE ISSUE. THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 6635504 ↗
• MalfunctionJun 12, 2017No Display/Image; No Display/Image

  IT WAS REPORTED THAT, AN 840 VENTILATOR HAD A FAULTY DISPLAY. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THE EVENT OCCURRED. THE SERVICE ENGINEER (SE) VERIFIED THE MALFUNCTION AND REPLACED THE GRAPHICAL USER INTERFACE (GUI) PRINTED CIRCUIT BOARD (PCB) AND THE BACKLIGHT INVERTER PCB¿S WERE UPDATED. THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 6633173 ↗
• MalfunctionJun 8, 2017Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT, AN 840 VENTILATOR HAD UNRESPONSIVE KEYBOARD. 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 KEYBOARD ASSEMBLY. THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 6622586 ↗
• MalfunctionMay 30, 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. THE COVIDIEN SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND REPLACED THE TOUCH FRAME TO CORRECT THE ISSUE. THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 6597926 ↗
• InjuryMay 25, 2017Device Inoperable; Device Inoperable

  IT WAS REPORTED AN 840 VENTILATOR STOPPED DURING VENTILATION. THE VENTILATOR GENERATED A GUI INOPERABLE ERROR. THE TECHNICIAN INSPECTED THE DEVICE AND PERFORMED AN EXTENDED SELF TEST (EST). THE VENTILATOR PASSED THE EST. UNIT IS NOT IN USE AS THE TECHNICIAN WISHES TO DISCUSS ERROR LOG WITH MANUFACTURER. ALTHOUGH REQUESTED, INFORMATION PERTAINING TO THE PATIENT OUTCOME HAS NOT BEEN PROVIDED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Code Available; No Information

  MAUDE report 6590381 ↗
• MalfunctionMay 23, 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. 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 Patient Involvement

  MAUDE report 6584458 ↗
• MalfunctionMay 22, 2017Device Inoperable; Device Inoperable

  IT WAS REPORTED THAT AN 840 VENTILATOR HAD A POST (POWER ON SELF TEST) FAILURE. THE VENTILATOR WAS NOT ON A PATIENT AT THE TIME OF THE EVENT. THE COVIDIEN SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND REPLACED THE 2 DALLAS DS1286 REAL TIME RECORDERS ON GUI AND BD DISCS TO CORRECT THE ISSUE. REQUIRED TESTS AND CALIBRATIONS FOR THIS REPAIR WERE COMPLETED IN ACCORDANCE WITH CURRENT SERVICE MANUAL.

  Patient problems: No Patient Involvement

  MAUDE report 6583628 ↗
• MalfunctionMay 16, 2017Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT AN 840 VENTILATOR GENERATED LOSS OF COMMUNICATION ERRORS AND BECAME INOPERABLE. THE VENTILATOR WAS NOT IN USE AT THE TIME OF THE REPORTED EVENT. THE REPAIRS OF THE VENTILATOR HAVE NOT BEEN COMPLETED AT THIS TIME.

  Patient problems: No Patient Involvement

  MAUDE report 6570768 ↗
• MalfunctionMay 6, 2017Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT, AN 840 VENTILATOR HAD UNRESPONSIVE KEYBOARD. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME THE MALFUNCTION OCCURRED. THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND REPLACED THE KEYBOARD ASSEMBLY. THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS

  Patient problems: No Patient Involvement

  MAUDE report 6550743 ↗