Puritan Bennett 10049998Recalls & reported problems

Summary

The FDA's MAUDE database contains 102 adverse event reports that list this exact device (DI 10884521181045), received between Jun 1, 2017 and Jun 11, 2026 — classified as 2 deaths, 2 injuries, 98 malfunctions.

The most frequently reported specific device problem is “No Flow” (66 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 102 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2026No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE 840 VENTILATOR GENERATED A BACKGROUND CHECK BREATH DELIVERY UNIT (BDU) ALERT INDICATING A BD ELECTRICALLY ERASABLE PROGRAMMABLE READ ONLY MEMORY (EEPROM) CHECKSUM ERROR, WHICH COULD LEAD TO LOSS OF VENTILATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25479897 ↗
• MalfunctionApr 24, 2026No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE 840 VENTILATOR ALARMED AND THE UNIT WAS IN AN "INOPERATIVE" CONDITION. THE UNIT STOPPED DELIVERING BREATHS TO THE PATIENT. THE PATIENT WAS REMOVED FROM THE VENTILATOR, WAS MANUALLY VENTILATED, AND WAS PLACED IN AN ALTERNATE VENTILATOR WITHOUT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24985377 ↗
• MalfunctionFeb 19, 2026No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS 840 VENTILATOR STOPPED VENTILATION WITH A VENT INOP MESSAGE DISPLAYED. 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 24394358 ↗
• MalfunctionFeb 19, 2026No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE 840 VENTILATOR GENERATED A BREATH DELIVERY UNIT (BDU) BACKGROUND CHECK INDICATING EXPIRATORY PRESSURE AUTOZERO OFFSET FAILED, VENTILATION STOPPED AND SAFETY VALVE OPENED. THE PATIENT EXPERIENCED TRANSIENT DESATURATION TO 73% WHICH RESOLVED AFTER MANUAL VENTILATION AND TRANSFER TO AN ALTERNATE VENTILATOR.

  Patient problems: Low Oxygen Saturation

  MAUDE report 24394137 ↗
• MalfunctionJan 23, 2026No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE 840 VENTILATOR STOPPED WORKING AND HAD A LOSS OF VENTILATION. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND WAS PLACED IN AN ALTERNATE VENTILATOR. THERE WAS NO REPORTED INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24163925 ↗
• MalfunctionJul 9, 2025Failure to Calibrate; No Flow; Failure to Calibrate; No Flow

  IT WAS REPORTED THAT THIS 840 VENTILATOR GENERATED AN EXPIRATORY VALVE TEMPERATURE OUT OF RANGE (OOR) MESSAGE AND FAILED THE FLOW SENSOR CALIBRATION. 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 22464436 ↗
• MalfunctionMar 11, 2025No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS 840 VENTILATOR GENERATED A BREATH DELIVERY (BD) ERROR CODE AND STOPPED VENTILATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21579036 ↗
• MalfunctionDec 6, 2024No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE 840 VENTILATOR DID NOT CONTINUE TO DELIVER BREATHS POST SUCTION. 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 20866135 ↗
• MalfunctionNov 22, 2024No Flow; No Flow

  IT WAS REPORTED THAT WHILE THE 840 VENTILATOR WAS IN USE ON A PATIENT, THE SAFETY VALVE OPENED. 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 20764995 ↗
• MalfunctionOct 3, 2024Defective Alarm; Noise, Audible; Defective Alarm; Noise, Audible

  IT WAS REPORTED THAT THESE 840 VENTILATORS HAD NO AUDIBLE ALARM AND A BUZZING NOISE WAS HEARD FROM THE MONITOR AREA. 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 20364182 ↗
• MalfunctionSep 26, 2024No Flow; No Flow

  IT WAS REPORTED BY THE NATIONAL HEALTH SURVEILLANCE AGENCY (ANVISA), THAT THE 840 VENTILATOR TURNED OFF UNEXPECTEDLY WHILE THE PATIENT WAS CONNECTED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 20312749 ↗
• MalfunctionSep 6, 2024No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PEDIATRIC PATIENT, THE 840 VENTILATOR ABRUPTLY BECAME INOPERABLE AND STOPPED FUNCTIONING. THE PATIENT WAS MANUALLY VENTILATED AND WAS TRANSFERRED TO AN ALTERNATE VENTILATOR WITHOUT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20154980 ↗
• MalfunctionAug 6, 2024No Flow; Power Problem; No Flow; Power Problem

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS 840 VENTILATOR SHUT DOWN. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 19925020 ↗
• MalfunctionJun 12, 2024No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS 840 VENTILATOR"TURNED OFF". THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19524801 ↗
• MalfunctionJun 5, 2024Defective Alarm; Defective Alarm

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS 840 VENTILATOR GENERATED AN ¿AUTOZERO VALVE FAULT MESSAGE WITH NO AUDIBLE ALARM". THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19473231 ↗
• MalfunctionAug 24, 2023Smoking; Smoking

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE 840 VENTILATOR WAS OBSERVED TO HAVE SPARKED ON THE BACK OF THE SCREEN. IT WAS ALSO REPORTED THAT THE VENTILATOR HAD A BURNT SCREEN AND EMANATED A BURNT 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 17614824 ↗
• MalfunctionJun 2, 2023No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE 840 VENTILATOR STOPPED CYCLING. THE PATIENT OUTCOME AND INTERVENTION WERE ASKED BUT UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17054637 ↗
• MalfunctionFeb 13, 2023No Flow; No Flow

  IT WAS REPORTED THAT DURING USE, THIS 840 VENTILATOR GENERATED A CONTINUOUS ALARM, A SYSTEM ERROR, AND A DEVICE ALERT INDICATING THAT THE BREATH EMISSION STATUS WAS NOT ABLE TO BE DETERMINED. IT WAS ALSO REPORTED THAT THE DEVICE SCREEN HAD NO DISPLAY. THE PATIENT DEVELOPED TACHYPNEA AND DYSPNEA. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND IMMEDIATELY CONNECTED TO ANOTHER OXYGEN SOURCE (WALL CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) WITHOUT INJURY.

  Patient problems: Increased Respiratory Rate

  MAUDE report 16369238 ↗
• MalfunctionJan 23, 2023No Flow; Output Problem; No Flow; Output Problem

  UPDATED: IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS 840 VENTILATOR STOPPED DELIVERING BREATHS TO THE PATIENT AND TURNED OFF. THE PATIENT WAS TRANSFERRED TO AN ALTERNATE VENTILATOR WITHOUT INJURY. ALTHOUGH A LOSS OF VENTILATION WAS REPORTED, BASED ON THE REVIEW OF THE LOGS THERE IS NO EVIDENCE THAT THE CODES REPORTED OCCURRED WHILE IN USE ON A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16229476 ↗
• MalfunctionJan 13, 2023No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS 840 VENTILATOR GENERATED A DIAGNOSTIC CODE INDICATING AN AIR PROPORTIONAL SOLENOID (PSOL) STUCK-OPEN MESSAGE AND THE UNIT SHUTDOWN. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND MANUALLY VENTILATED BEFORE BEING PLACED TO AN ALTERNATE VENTILATOR WITHOUT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16158229 ↗
• MalfunctionDec 29, 2022Smoking; Smoking

  IT WAS REPORTED THAT, DURING PREVENTATIVE MAINTENANCE BY THE CUSTOMER, THIS 840 VENTILATOR FAILED THE BATTERY TEST DURING THE EXTENDED SELF-TEST (EST). AFTER CHANGING THE BATTERY PACK, PLUGGING THE POWER SUPPLY BACK IN, AND TURNED ON, THE DEVICE CONTINUOUSLY ALARMED, THE SCREEN WENT BLACK, AND SMOKE CAME OUT OF THE UNIT. 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 16070360 ↗
• MalfunctionOct 14, 2022No Flow; No Flow

  IT WAS REPORTED THAT THE 840 VENTILATOR CONTINUED TO VENTILATE THE PATIENT WHEN THE UNIT GENERATED A BREATH DELIVERY (BD) ELECTRICALLY ERASABLE PROGRAMMABLE READ-ONLY MEMORY (EEPROM) BACKGROUND CHECK BREATH DELIVERY UNIT (BDU) ALARM. THE PATIENT WAS BAGGED BEFORE TRANSFERRING TO AN ALTERNATE VENTILATOR WITHOUT INJURY. ALTHOUGH THE CUSTOMER REPORTED THAT THE DEVICE CONTINUED TO DELIVER BREATHS, THE VENTILATOR WOULD GO INTO AN INOPERATIVE CONDITION AND THE DIAGNOSTIC CODE GENERATED WOULD LEAD TO LOSS OF VENTILATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15607536 ↗
• MalfunctionAug 22, 2022No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE 840 VENTILATOR GENERATED AN ALARM AND THE UNIT SHUTDOWN. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND WAS PLACED ON AN ARTIFICIAL MANUAL BREATHING UNIT (AMBU) BEFORE TRANSFERRING TO AN ALTERNATE VENTILATOR WITHOUT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15266876 ↗
• MalfunctionAug 2, 2022Communication or Transmission Problem; No Flow; Communication or Transmission Problem; No Flow

  IT WAS REPORTED THAT THE 840 VENTILATOR SUDDENLY SHUT OFF AND FAILED TO CONTINUE DELIVERING BREATHS 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 15147927 ↗
• MalfunctionAug 2, 2022No Flow; No Flow

  IT WAS REPORTED THAT DURING USE ON A PATIENT, THIS 840 VENTILATOR BEGAN TO ALARM AND TURNED OFF. IT WAS REPORTED THAT THE PATIENT DIED DUE TO ACUTE GASTROINTESTINAL BLEEDING AND THAT THE VENTILATOR DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT OF THE PATIENT'S DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15147556 ↗