Puritan Bennett 4-840220ASAA-ENRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521076990), received between May 11, 2017 and Jun 6, 2019 — classified as 2 injuries, 7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 6, 2019No Flow; No Flow

  IT WAS REPORTED DURING USE THE 840 VENTILATOR STOPPED VENTILATING AND GENERATED A DEVICE ALERT " NO VENTILATION SAFETY VALVE OPEN". THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8674424 ↗
• MalfunctionSep 24, 2018No Flow; No Flow

  ADDITIONAL INFORMATION RECEIVED AS FOLLOWS: THE PATIENT WAS TRANSFERRED TO AN ALTERNATE VENTILATOR WITHOUT HARM OR INJURY.

  Patient problems: No Code Available; No Consequences Or Impact To Patient; No Information

  MAUDE report 7903536 ↗
• MalfunctionAug 13, 2018No Flow; No Flow

  IT WAS REPORTED THAT DURING USE, THE 840 VENTILATOR SHUT DOWN. THE UNIT RESTARTED BUT WOULD NOT VENTILATE. THE PATIENT WAS REMOVED AND MANUALLY VENTILATED. A GRAPHICAL USER INTERFACE (GUI) RESET ERROR CODE WAS PROVIDED. THE PATIENT WAS THEN TRANSFERRED TO AN ALTERNATE VENTILATOR AND THERE WAS NO HARM OR INJURY TO THE PATIENT AS A RESULT OF THE EVENT. THE PATIENT REMAINED STABLE.

  Patient problems: No Code Available

  MAUDE report 7778386 ↗
• MalfunctionNov 8, 2017Device Inoperable; Device Inoperable

  THE CUSTOMER REPORTED THAT DURING USE AN 840 VENTILATOR SHUT DOWN ON A PATIENT. NO SOUNDS OF VENTILATION AND NO RUSH OF AIR WHEN DISCONNECTING THE PATIENT. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Code Available

  MAUDE report 7009811 ↗
• MalfunctionOct 2, 2017Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT AN 840 VENTILATOR HAD A SMOKING SMELL FROM THE REAR OF THE UNIT AND AN ALARM WAS GENERATED. THE ALARM CODE INDICATED A POTENTIAL POWER SUPPLY ISSUE. ALTHOUGH REQUESTED, IT IS UNKNOWN IF A PATIENT WAS CONNECTED TO THE VENTILATOR AT THE TIME OF THE EVENT.

  Patient problems: No Code Available; No Information

  MAUDE report 6909225 ↗
• MalfunctionAug 3, 2017Battery Problem; Battery Problem

  IT WAS REPORTED THAT AN 840 VENTILATOR BATTERY WAS NOT CHARGING. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE EVENT. THE SERVICE ENGINEER REPLACED THE LITHIUM BATTERY TO ADDRESS THE ISSUE. THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 6765667 ↗
• InjuryJul 12, 2017Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT, AN 840 VENTILATOR HAD A INTERMITTENT RESET DISPLAY WHILE DEVICE WAS IN USE ON A PATIENT. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR. THE COVIDIEN TECHNICAL SUPPORT ENGINEER (TSE) TROUBLESHOT THIS ISSUE WITH THE CUSTOMER OVER THE PHONE, AND CUSTOMER WAS ADVISE TO REPLACE THE GRAPHIC USER INTERFACE (GUI) PRINTED CIRCUIT BOARD (PCB) AND COVIDIEN SERVICE ENGINEER WILL INSTALL THE OPERATIONAL SOFTWARE. ONSITE BIOMED WILL COMPLETE THE REPAIR. COVIDIEN WAS NOT AUTHORIZED TO SERVICE THE DEVICE.

  Patient problems: No Code Available

  MAUDE report 6706133 ↗
• InjuryMay 24, 2017No Display/Image; No Display/Image

  IT WAS REPORTED THAT AN 840 VENTILATOR HAD A COMMUNICATIONS ERROR GENERATED. THE VENTILATOR WAS REPLACED. THERE WAS NO INJURY REPORTED, VENTILATION DID NOT STOP. THE EVALUATION AND REPAIR OF THE DEVICE HAS NOT BEEN COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6588620 ↗
• MalfunctionMay 11, 2017Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT AN 840 VENTILATOR HAD AN ERRATIC DISPLAY. AT THIS TIME, IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. TO ADDRESS THE FAILURE, A SERVICE ENGINEER (SE) REPLACED THE GRAPHICAL USER INTERFACE (GUI) PRINTED CIRCUIT BOARD (PCB). THE UNIT PASSED ALL TESTING AND OPERATES WITHIN THE MANUFACTURING SPECIFICATIONS.

  Patient problems: No Information

  MAUDE report 6559994 ↗