Puritan Bennett 4-840220DIPC-PRRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521077102), received between May 10, 2017 and Sep 27, 2018 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (2 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 27, 2018No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE 840 VENTILATOR STOPPED VENTILATING. THE PATIENT WAS PLACED ON AN ALTERNATE VENTILATOR AND THERE WERE NO SIGNIFICANT CONSEQUENCES TO THE PATIENT AS A RESULT OF THE EVENT.

  Patient problems: No Code Available

  MAUDE report 7915914 ↗
• MalfunctionAug 23, 2017Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT AN 840 VENTILATOR HAD A TOUCH SCREEN THAT WAS BLOCKED. ALTHOUGH REQUESTED, IT IS UNKNOWN IF THE PATIENT WAS CONNECTED TO THE VENTILATOR AT THE TIME OF THE EVENT. THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND CLEANED THE DISPLAY. THE SE PERFORMED TESTING AND CALIBRATIONS AND THE VENTILATOR OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Information

  MAUDE report 6814702 ↗
• MalfunctionJul 17, 2017Contamination; Contamination

  IT WAS REPORTED THAT, AN 840 VENTILATOR HAD A TOUCH SCREEN CONTAMINATED WITH LIQUID. 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 GRAPHICAL USER INTERFACE (GUI) TOUCH FRAME PRINTED CIRCUIT BOARD (PCB). THE UNIT PASSED ALL TESTING AND OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 6719852 ↗
• MalfunctionJul 11, 2017Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT AN 840 VENTILATOR HAD A COMMUNICATION ERROR WITH THE BREATH DELIVERY UNIT (BDU) PRINTED CIRCUIT BOARD (PCB). THE VENTILATOR WAS NOT ON A PATIENT AT THE TIME OF THE EVENT. THE SERVICE ENGINEER INSPECTED THE DEVICE AND REPLACED THE BDU PCB CONNECTION CABLE, TO CORRECT THE ISSUE. THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 6702373 ↗
• MalfunctionJun 6, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE, THE VENTILATOR HAD A KEYBOARD MALFUNCTION. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT. THE SERVICE ENGINEER INSPECTED THE DEVICE AND FOUND FLUID INGRESS ON THE KEYBOARD. THE SE CLEANED THE TOUCH FRAME PRINTED CIRCUIT BOARD (PCB). THE VENTILATOR PASSED ALL TESTING AND OPERATES WITHIN MANUFACTURING SPECIFICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 6616589 ↗
• MalfunctionMay 12, 2017Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT AN 840 VENTILATOR HAD AN INTERMITTENTLY BLOCKED TOUCHSCREEN. AT THIS TIME, IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. A SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND CONFIRMED THE REPORTED CONDITION. THEY FOUND LIQUID INFILTRATION ON THE FRONT HOUSING OF THE TOUCHSCREEN. TO RESOLVE THE ISSUE, SE REPLACED THE GRAPHICAL USER INTERFACE (GUI) TOUCHSCREEN, GUI KEYBOARD, AND GUI FRONT HOUSING. THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Information

  MAUDE report 6563186 ↗
• MalfunctionMay 10, 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 THE MALFUNCTION 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 UPGRADED. THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 6559024 ↗
• MalfunctionMay 10, 2017Device Inoperable; Device Inoperable

  IT WAS REPORTED THAT AN, 840 VENTILATOR GENERATED ERROR CODE WHICH RENDERED THE VENTILATOR INOPERABLE WITH SAFETY VALVE OPEN CONDITION. 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 BREATH DELIVERY UNIT (BDU) PRINTED CIRCUIT BOARD (PCB). THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 6557393 ↗
• MalfunctionMay 10, 2017Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT AN 840 VENTILATOR HAD A HARD KEYBOARD. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED CONDITION. TO RESOLVE THE ISSUE, A SERVICE ENGINEER (SE) REPLACED THE KEYBOARD. THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 6556564 ↗