Puritan Bennett 4-840120DIJJ-JPRecalls & reported problems

Summary

The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 10884521076891), received between Apr 2, 2018 and Sep 28, 2026 — classified as 87 malfunctions.

The most frequently reported specific device problem is “No Flow” (76 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 87 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026No Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926361 ↗
• MalfunctionFeb 10, 2026No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE 840 VENTILATOR GENERATED A BACKGROUND CHECK ALERT DIAGNOSTIC CODE INDICATING BAD BREATH DELIVERY (BD) 12 VOLTS SUPPLY AND VENTILATION STOPPED. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND WAS PLACED IN AN ALTERNATE VENTILATOR. THE PATIENT THEN PASSED AWAY DUE TO AN UNDERLYING DISEASE, AND THE DEATH WAS NOT CAUSALLY RELATED TO THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24309002 ↗
• MalfunctionDec 23, 2025No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS 840 VENTILATOR GENERATED DIAGNOSTIC CODES WHICH INDICATED AIR PROPORTIONAL SOLENOID VALVE (PSOL) STUCK OPEN AND LOSS OF BREATH DELIVERY (BD) COMMUNICATION, 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 23878806 ↗
• MalfunctionOct 15, 2025No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE 840 VENTILATOR GENERATED A DIAGNOSTIC CODE INDICATING A BREATH DELIVERY UNIT (BDU) BACKGROUND CHECK WITH A MESSAGE OF INSPIRATORY PRESSURE AUTOZERO OFFSET ¿FAILED.¿ 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 23305444 ↗
• MalfunctionSep 16, 2025No Flow; No Flow

  IT WAS REPORTED THAT DURING USE ON A PATIENT, THE 840 VENTILATOR GENERATED AN ALARM INDICATING THAT THE VENTILATION STOPPED WITH DI AGNOSTIC CODE. 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 23065011 ↗
• MalfunctionSep 5, 2025Device Emits Odor; No Flow; Device Emits Odor; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THESE 840 VENTILATOR DISPLAYED ALARMS INDICATING LOSS OF VENTILATION AS WELL AS EMITTED A BURNING SMELL. 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 22978915 ↗
• MalfunctionAug 22, 2025No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS PB840 VENTILATOR ALARMED AND DISPLAYED AN "OPERATION FAILURE" MESSAGE. VENTILATION STOPPED, AND THE SAFETY VALVE OPEN (SVO) LIGHT WAS ON. 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 22873564 ↗
• MalfunctionMar 18, 2025No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE 840 VENTILATOR GENERATED A BACKGROUND CHECK ALERT MESSAGE INDICATING AIR PROPORTIONAL SOLENOID (PSOL) STUCK OPEN. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND WAS PLACED ON AN ALTERNATE VENTILATOR WITHOUT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21637010 ↗
• MalfunctionDec 12, 2024No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE 840 VENTILATOR "STOPPED CYCLING" AND THE UNIT GENERATED A LOW-VOLTAGE REFERENCE OUT OF RANGE AND BACKGROUND CHECK (BREATH DELIVERY UNIT (BDU) DIAGNOSTIC CODES. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITHOUT INJURY. A REVIEW OF THE VENTILATOR LOGS CONFIRMED THE "STOPPED CYCLING"/LOSS OF VENTILATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20918816 ↗
• MalfunctionOct 22, 2024No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE 840 VENTILATOR GENERATED AN OPERATION FAILURE ALARM SOUND AND ALSO GENERATED A POWER ON SELF TEST DIAGNOSTIC MESSAGE AND A BACKGROUND CHECK ALERT DIAGNOSTIC MESSAGE INDICATING NON-VOLATILE RANDOM ACCESS MEMORY (NOVRAM) CHECKSUM ERROR, AND VENTILATION STOPPED. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND WAS PLACED ON AN ALTERNATE VENTILATOR WITHOUT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20509106 ↗
• MalfunctionJul 25, 2024No Flow; Output Problem; No Flow; Output Problem

  IT WAS REPORTED THAT THIS 840 VENTILATOR GENERATED AN ALARM, DISPLAYED AN "AIR SUPPLY CANNOT BE CONFIRMED" MESSAGE, A POWER ON SELF TEST (POST) BREATH DELIVERY UNIT (BDU) AND LOSS OF BREATH DELIVERY COMMUNICATION ALERT. 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 19830920 ↗
• MalfunctionJul 2, 2024No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS 840 VENTILATOR GENERATED AN ALARM AND THE SAFETY VALVE OPENED. 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 19659168 ↗
• MalfunctionJun 14, 2024No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE 840 VENTILATOR GENERATED AN "ABNORMAL" ALARM AND THE 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 19542660 ↗
• MalfunctionJun 13, 2024No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE 840 VENTILATOR ALARMED, GENERATED DIAGNOSTIC CODES, SAFETY VALVE OPENED, AND VEN TILATION STOPPED. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND WAS PLACED ON AN ALTERNATE VENTILATOR WITHOUT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19532266 ↗
• MalfunctionJan 12, 2024No Flow; No Flow

  IT WAS REPORTED THAT THE 840 VENTILATOR GENERATED AN "OPERATION FAILURE" ALARM, VENTILATION STOPPED AND SAFETY VALVE OPENED (SVO) WHILE THE PATIENT WAS CONNECTED. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND WAS PLACED ON AN ALTERNATE VENTILATOR WITHOUT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18508765 ↗
• MalfunctionJan 9, 2024No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE PB840 VENTILATOR GENERATED A BACKGROUND CHECK ALERT DIAGNOSTIC CODE AND VENTILATION STOPPED. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND WAS PLACED ON AN ALTERNATE VENTILATOR WITHOUT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18480566 ↗
• MalfunctionJan 4, 2024No Flow; Output Problem; No Flow; Output Problem

  IT WAS REPORTED THAT THIS 840 VENTILATOR GENERATED A PROCESSING PROCEDURE ERROR WHEN TURNED ON. THE VENTILATOR WAS NOT IN USE ON A P ATIENT AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18447547 ↗
• MalfunctionDec 27, 2023No Flow; Output Problem; No Flow; Output Problem

  IT WAS REPORTED THAT THIS 840 VENTILATOR GENERATED A PROCESSING ERROR WHEN TURNED ON. 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 18405953 ↗
• MalfunctionDec 21, 2023No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS 840 VENTILATOR GENERATED A DIAGNOSTIC CODE 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 18379075 ↗
• MalfunctionDec 21, 2023No Flow; No Flow

  IT WAS REPORTED THAT THE 840 VENTILATOR GENERATED AN USUAL ALARM AND THE UNIT STOPPED VENTILATION WHILE THE PATIENT WAS CONNECTED. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND WAS PLACED ON AN ALTERNATE VENTILATOR WITHOUT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18377428 ↗
• MalfunctionDec 18, 2023No Flow; Output Problem; No Flow; Output Problem

  IT WAS REPORTED THAT DURING SERVICING, THE 840 VENTILATOR DISPLAYED A "PROCESSING ERROR" MESSAGE. 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 18351250 ↗
• MalfunctionNov 10, 2023No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS 840 VENTILATOR GENERATED AN ALARM INDICATING BREATH DELIVERY (BD) NONVOLATILE RAM (NOVRAM) CHECKSUM ERROR, VENTILATION STOPPED AND SAFETY VALVE OPENED (SVO). 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 18112648 ↗
• MalfunctionOct 2, 2023Smoking; Smoking

  IT WAS REPORTED THAT DURING SERVICING, THE 840 VENTILATOR EMITTED SMOKE AND A STRANGE ODOR FROM THE BREATH DELIVERY UNIT (BDU) SECTION. 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 17854057 ↗
• MalfunctionDec 2, 2022No Flow; No Flow

  UPDATED: IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS 840 VENTILATOR GENERATED A SAFETY VALVE OPEN MESSAGE AND A BAD SAFETY VALVE CURRENT DIAGNOSTIC CODE. THERE WAS NO REPORTED PATIENT INJURY. ALTHOUGH REQUESTED, PATIENT INTERVENTION WAS UNKNOWN AT THIS TIME.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15906511 ↗
• MalfunctionNov 21, 2022No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE SCREEN OF THIS 840 VENTILATOR SUDDENLY BLACKED OUT AND VENTILATION STOPPED WHEN THE SAFETY VALVE OPENED. 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 15836115 ↗