Puritan Bennett 4-840120DIUU-USRecalls & reported problems

Summary

The FDA's MAUDE database contains 159 adverse event reports that list this exact device (DI 10884522019354), received between Mar 26, 2018 and Jul 31, 2025 — classified as 1 death, 158 malfunctions.

The most frequently reported specific device problem is “No Flow” (115 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 159 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2025No Flow; No Flow

  UPDATE: IT WAS REPORTED THROUGH A MEDWATCH REPORT FROM THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) AND NOT DIRECTLY FROM THE CUSTOMER, THAT WHILE IN USE ON A PATIENT, THE 840 VENTILATOR PRODUCED A HIGH PITCHED WHISTLING SOUND THAT COULD NOT BE SILENCED. THE UNIT BECAME INOPERATIVE AND WAS UNABLE TO DELIVER ANY BREATHS TO THE PATIENT. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITHOUT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22680350 ↗
• MalfunctionDec 15, 2023No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS 840 VENTILATOR GENERATED AN ALARM AND GENERATED A DIAGNOSTIC MESSAGE INDICATING BAD EXPIRATORY FLOW BACKGROUND CHECK BREATH DELIVERY UNIT (BDU) AND VENTILATION STOPPED. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITHOUT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18340526 ↗
• MalfunctionAug 17, 2023No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS 840 VENTILATOR DISPLAYED A NO VENTILATION MESSAGE AND WHEN ATTEMPTED TO RESET, THE UNIT BECAME INOPERATIVE. THE PATIENT WAS MANUALLY BAGGED THEN PLACED ON AN ALTERNATE VENTILATOR WITHOUT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17569303 ↗
• MalfunctionMar 2, 2023No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS 840 VENTILATOR SHUTDOWN. THE PATIENT WAS PLACED ON AN ALTERNATE VENTILATOR WITHOUT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16469127 ↗
• MalfunctionJan 25, 2023No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE 840 VENTILATOR GENERATED AN INSPIRATORY PRESSURE STUCK BACKGROUND CHECK BREATH DELIVERY UNIT (BDU). THE PATIENT WAS REMOVED FROM THE VENTILATOR AND WAS ASSISTED BY A BREATHING BAG BEFORE TRANSFERRING TO AN ALTERNATE VENTILATOR WITHOUT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16243459 ↗
• MalfunctionNov 10, 2022No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS 840 VENTILATOR SCREEN WENT BLANK AND THE VENTILATOR SHUT DOWN. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITHOUT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15777291 ↗
• MalfunctionOct 28, 2022No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS 840 VENTILATOR GENERATED AN ALARM AND A SERVICE MESSAGE WAS DISPLAYED ON TOP. A DDITIONALLY, IT WAS REPORTED THAT THE VENTILATOR WENT BLACK AND TURNED OFF. THE PATIENT WAS BAGGED AND TRANSFERRED TO AN ALTERNATE VENTILATOR WITHOUT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15693072 ↗
• MalfunctionOct 14, 2022No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT DURING ENDOTRACHEAL SUCTION, THIS 840 VENTILATOR GENERATED A SAFETY VALVE OPEN ALARM, AN AIR PSOL (PROPORTIONAL SOLENOID VALVE ASSEMBLY) STUCK OPEN AND BACKGROUND CHECK DIAGNOSTIC CODES AND VENTILATION STOPPED. THE PATIENT WAS PLACED ON AN ALTERNATE VENTILATOR WITHOUT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15607801 ↗
• MalfunctionAug 10, 2022No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE 840 VENTILATOR WAS IN AN "INOPERATIVE" CONDITION AND GENERATED A INSPIRATORY PRESSURE STUCK DIAGNOSTIC CODE. THE PATIENT WAS TRANSFERRED TO AN ALTERNATE VENTILATOR WITHOUT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15202439 ↗
• DeathMay 23, 2022Disconnection; Disconnection

  IT WAS REPORTED THAT WHILE THE NURSES WERE MOVING A DNR (DO NOT RESUSCITATE) PATIENT, THE CIRCUIT OF THIS 840 VENTILATOR GOT DISCONNECTED AND THE VENTILATOR GENERATED AN ALARM. THE NURSES WERE UNAWARE THAT THE ALARM BEING ANNUNCIATED WAS FOR CIRCUIT DISCONNECT. THE PATIENT DIED, HOWEVER, IT WAS DETERMINED THAT THE VENTILATOR WAS NOT AT FAULT AND IT DID NOT CAUSE OR CONTRIBUTE TO THE EVENT.

  Patient problems: Respiratory Arrest

  MAUDE report 14470923 ↗
• MalfunctionJan 24, 2022No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS 840 VENTILATOR GENERATED A BACKGROUND CHECK BREATH DELIVERY UNIT (BDU) DIAGNOSTIC MESSAGE INDICATING A LOSS OF VENTILATION. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITHOUT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13338224 ↗
• MalfunctionNov 24, 2021No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS 840 VENTILATOR POWERED OFF. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITHOUT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12872025 ↗
• MalfunctionNov 22, 2021No Flow; No Flow

  IT WAS REPORTED THAT THIS 840 VENTILATOR HAD RED LIGHTS ON AND STOPPED VENTILATING WHILE IN USE ON A PATIENT. A BREATHING BAG WAS USED AND THE PATIENT WAS PLACED ON AN ALTERNATE VENTILATOR WITHOUT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12853794 ↗
• MalfunctionSep 30, 2021No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS 840 VENTILATOR WAS IN AN "INOPERATIVE" AND SAFETY VALVE OPEN (SVO) CONDITION. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITHOUT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12558649 ↗
• MalfunctionSep 21, 2021No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS 840 VENTILATOR GENERATED DIAGNOSTIC CODES AND SHUTDOWN. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITHOUT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12509868 ↗
• MalfunctionJul 19, 2021Smoking; Smoking

  IT WAS REPORTED THAT SMOKE EMITTED FROM THIS 840 VENTILATOR'S POWER SUPPLY. 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 12188507 ↗
• MalfunctionMar 17, 2021No Flow; Output Problem; No Flow; Output Problem

  IT WAS REPORTED THAT THE 840 VENTILATOR LOGGED A POST (POWER ON SELF TEST) FAILURE ERROR CODE. 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 11507816 ↗
• MalfunctionFeb 4, 2021No Flow; No Flow

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, THE 840 VENTILATOR GENERATED AN ALARM AND VENTILATION STOPPED. ALTHOUGH REQUESTED, INTERVENTION TAKEN ON BEHALF OF THE PATIENT WAS NOT PROVIDED; HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11281456 ↗
• MalfunctionFeb 2, 2021No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE 840 VENTILATOR'S SAFETY VALVE OPENED AND THE VENTILATOR TURNED OFF. IT WAS ADDITIONALLY REPORTED THAT THE VENTILATOR DID NOT CONTINUE TO DELIVER BREATHS TO THE PATIENT AT THE TIME OF THE REPORTED EVENT. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11267500 ↗
• MalfunctionJan 11, 2021Defective Alarm; No Flow; Defective Alarm; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS 840 VENTILATOR SHOWED "0" VT (TIDAL VOLUME). ADDITIONALLY, THE VENTILATOR STOPPED DELIVERING BREATHS TO THE PATIENT. THERE WAS NO ALARM GENERATED. THE VENTILATOR WAS CHANGED BUT THEY THINK THAT IT WAS THE PATIENT/CLINICAL CONDITION. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11152115 ↗
• MalfunctionDec 23, 2020No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS 840 VENTILATOR STOPPED WORKING AND GENERATED VENTILATOR INOPERATIVE DIAGNOSTIC CODES. THE PATIENT WAS MANUALLY VENTILATED VIA AN AMBU BAG PRIOR TO TRANSFERRING TO AN ALTERNATE VENTILATOR WITHOUT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11066272 ↗
• MalfunctionNov 30, 2020No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE 840 VENTILATOR STOPPED VENTILATING AND GENERATED A BREATH DELIVERY UNIT (BDU) BA CKGROUND CHECK CODE WHICH INDICATED THAT THE INSPIRATORY PRESSURE TRANSDUCER WAS STUCK. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITHOUT HARM AS THE RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10920439 ↗
• MalfunctionNov 30, 2020No Flow; Power Problem; No Flow; Power Problem

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE 840 VENTILATOR POWERED OFF AUTOMATICALLY. THE PATIENT WAS PLACED ON AN ALTERNATE VENTILATOR WITHOUT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10920292 ↗
• MalfunctionOct 7, 2020No Flow; No Flow

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, THE 840 VENTILATOR STOPPED VENTILATING AND STOPPED DELIVERING BREATHS TO THE PATIENT. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITHOUT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10645865 ↗
• MalfunctionSep 22, 2020No Flow; No Flow

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT AND WHILE DRAINING WATER FROM THE CIRCUIT, THE 840 VENTILATOR WENT INTO AN INOPERABLE CONDITION AND STOPPED DELIVERING BREATHS. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND MANUALLY VENTILATED VIA AN AMBU BAG BEFORE BEING PLACED ON AN ALTERNATE VENTILATOR WITH NO HARM OR INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10569772 ↗