Puritan Bennett 4-840220DIEC-RSRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521077041), received between Mar 20, 2017 and Aug 21, 2017 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Device Inoperable” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2017Device Inoperable; Device Inoperable

  IT WAS REPORTED THAT AN 840 VENTILATOR HAD A COMPRESSOR PERIODICALLY TURNING OFF, DUE TO A FUSE DISCONNECTION. THE VENTILATOR WAS NOT ON A PATIENT AT THE TIME OF THE EVENT. THE SERVICE ENGINEER REPLACED THE COMPRESSOR FILTER AND MUFFLER TO CORRECT THE ISSUE. THE UNIT PASSED ALL TESTING AND OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 6808192 ↗
• MalfunctionJul 26, 2017Calibration Problem; Calibration Problem

  IT WAS REPORTED AN 840 VENTILATOR HAD AN OXYGEN SENSOR THAT WOULD NOT CALIBRATE. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT. THE SERVICE ENGINEER REPLACED THE OXYGEN SENSOR TO ADDRESS THE ISSUE. THE UNIT PASSED ALL TESTING AND OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 6743947 ↗
• MalfunctionJul 25, 2017Device Inoperable; Device Inoperable

  IT WAS REPORTED THAT AN 840 VENTILATOR'S COMPRESSOR WAS NOT WORKING. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED INCIDENT. THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND REPLACED THE COMPRESSOR MUFFLER FILTERS TO ADDRESS THE ISSUE. THE UNIT PASSED ALL TESTING AND OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 6742823 ↗
• MalfunctionJun 5, 2017No Display/Image; No Display/Image

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

  Patient problems: No Patient Involvement

  MAUDE report 6613284 ↗
• MalfunctionMay 16, 2017Device Inoperable; Device Inoperable

  IT WAS REPORTED THAT AN 840 VENTILATOR HAD A BD (BREATH DELIVERY) POST (POWER ON SELF-TEST) FAILURE. THE VENTILATOR WAS NOT ON A PATIENT AT THE TIME OF THE EVENT. CUSTOMER DECLINED VENT REPAIR BY COVIDIEN SERVICE ENGINEER. CUSTOMER WILL CALL IF THEY DESIRE TO PERFORM THE REPAIR. COVIDIEN WAS NOT AUTHORIZED TO SERVICE THE DEVICE.

  Patient problems: No Patient Involvement

  MAUDE report 6570736 ↗
• MalfunctionMay 12, 2017Device Inoperable; Communication or Transmission Problem; Device Inoperable; Communication or Transmission Problem

  IT WAS REPORTED THAT AN 840 VENTILATOR BECAME INOPERABLE AND GENERATED A LOSS OF COMMUNICATION ERROR. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6563659 ↗
• MalfunctionApr 6, 2017Device Inoperable; Device Inoperable

  IT WAS REPORTED THAT, AN 840 VENTILATOR WENT INTO INOPERABLE 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 INSPIRATORY MODULE AND COMPRESSOR PCB. AND THE 15K PREVENTIVE MAINTENANCE WAS PERFORMED. THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 6464762 ↗
• MalfunctionMar 20, 2017No Display/Image; No Display/Image

  IT WAS REPORTED THAT, AN 840 VENT HAD A GUI DISPLAY FAULTY. ALTHOUGH REQUESTED, INFORMATION REGARDING THE INTERVENTION TAKEN ON THE BEHALF OF THE PATIENT HAS NOT BEEN PROVIDED. THE SERVICE ENGINEER (SE) VERIFIED THE MALFUNCTION AND REPLACED THE GRAPHICAL USER INTERFACE (GUI) PRINTED CIRCUIT BOARD (PCB) , THE BACKLIGHT INVERTER PCB¿S WERE UPGRADED. THE SOFTWARE WAS UPGRADED TO THE LATEST VERSION. THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Information

  MAUDE report 6417399 ↗