Puritan Bennett 4-840220DIUA-ENRecalls & reported problems

Summary

The FDA's MAUDE database contains 460 adverse event reports that list this exact device (DI 10884521077133), received between Mar 15, 2017 and Sep 28, 2026 — classified as 2 deaths, 3 injuries, 455 malfunctions.

The most frequently reported specific device problem is “Device Inoperable” (104 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 460 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 50926443 ↗
• MalfunctionSep 24, 2026No Flow

  Patient problems: Bradycardia; Low Oxygen Saturation

  MAUDE report 50891495 ↗
• MalfunctionJun 18, 2026No Flow

  IT WAS REPORTED BY THE NATIONAL MEDICAL AND PRODUCT ADMINISTRATION (NMPA), AND NOT REPORTED DIRECTLY TO MEDTRONIC BY THE CUSTOMER THAT WHILE IN USE ON A PATIENT, THE 840 VENTILATOR GENERATED A CONTINUOUS HARDWARE ALARM INDICATING AIR PROPORTIONAL SOLENOID (PSOL) STUCK OPEN AND THE UNIT WAS UNABLE TO OPERATE. THE PATIENT'S OXYGEN SATURATION DROPPED TO 95% AND RECOVERED AFTER UNIT REPLACEMENT. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND WAS PLACED IN AN ALTERNATE VENTILATOR WITHOUT INJURY.

  Patient problems: Low Oxygen Saturation

  MAUDE report 25553319 ↗
• MalfunctionFeb 12, 2026No Flow

  IT WAS REPORTED BY THE CHINA FOOD AND DRUG ADMINISTRATION (CFDA), ADVERSE REACTION EVENT CENTER OF (B)(6) , AND NOT REPORTED DIRECTLY TO MEDTRONIC BY THE CUSTOMER THAT WHILE IN USE ON A PATIENT, THIS 840 VENTILATOR DISPLAYED A HARDWARE ALARM ON SCREEN AND STOPPED DELIVERING BREATHS. 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 24327388 ↗
• MalfunctionDec 17, 2025No Flow; No Flow

  IT WAS REPORTED BY THE CHINA FOOD AND DRUG ADMINISTRATION (CFDA), ADVERSE REACTION EVENT CENTER OF SHANGHAI, AND NOT REPORTED DIRECTLY TO MEDTRONIC BY THE CUSTOMER, WHILE IN USE ON A PATIENT, THIS 840 VENTILATOR LOST POWER 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 23834587 ↗
• MalfunctionDec 4, 2025No Flow; No Flow

  IT WAS REPORTED BY THE CHINA FOOD AND DRUG ADMINISTRATION (CFDA), ADVERSE REACTION EVENT (B)(4), AND NOT REPORTED DIRECTLY TO MEDTRONIC BY THE CUSTOMER, THAT WHILE IN USE ON A PATIENT, THESE 840 VENTILATORS HAD A SUDDEN POWER "FAILURE." THE PATIENT WAS REMOVED FROM THE VENTILATOR, MANUALLY VENTILATED WITH A VENTILATOR BAG, AND THEN PLACED ON AN ALTERNATE VENTILATOR WITHOUT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23719764 ↗
• MalfunctionNov 20, 2025No Flow; No Flow

  IT WAS REPORTED BY THE CHINA FOOD AND DRUG ADMINISTRATION (CFDA), ADVERSE REACTION EVENT CENTER OF SHANGHAI, AND NOT REPORTED DIRECTLY TO MEDTRONIC BY THE CUSTOMER, THAT WHILE IN USE ON A PATIENT, THESE 840 VENTILATORS SUDDENLY ALARMED, INDICATING A HARDWARE FAILURE AND INABILITY TO VENTILATE. THE PATIENT¿S BLOOD PRESSURE INCREASED, HEART RATE ACCELERATED, AND OXYGEN SATURATION DROPPED TO 80%. THE PATIENT WAS REMOVED FROM THE VENTILATOR, AND OXYGEN WAS ADMINISTERED VIA A NEBULIZED MASK, RESULTING IN IMPROVED OXYGENATION; OXYGEN SATURATION INCREASED TO 99%, BLOOD PRESSURE WAS 115/56 MMHG, HEART RATE WAS 85 BPM, AND RESPIRATORY RATE WAS 21 BREATHS PER MINUTE. THE PATIENT WAS THEN PLACED ON AN ALTERNATE VENTILATOR WITHOUT INJURY.

  Patient problems: High Blood Pressure/ Hypertension; Low Oxygen Saturation; Tachycardia

  MAUDE report 23609331 ↗
• MalfunctionOct 15, 2025No Flow; No Flow

  IT WAS REPORTED BY THE CHINA FOOD AND DRUG ADMINISTRATION (CFDA), ADVERSE REACTION EVENT CENTER OF SHANGHAI, AND NOT REPORTED DIRECTLY TO MEDTRONIC BY THE CUSTOMER, THAT WHILE IN USE ON A PATIENT, THE 840 VENTILATOR SUDDENLY WENT "BLACK AND CRASHED." THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR WITH NO REPORTED INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23291558 ↗
• MalfunctionOct 15, 2025No Flow; No Flow

  IT WAS REPORTED BY THE CHINA FOOD AND DRUG ADMINISTRATION (CFDA), ADVERSE REACTION EVENT CENTER OF SHANGHAI, AND NOT REPORTED DIRECTLY TO MEDTRONIC BY THE CUSTOMER THAT WHILE IN USE ON A PATIENT, THE 840 VENTILATOR SHUT DOWN WITHOUT A WARNING. THE PATIENT WAS MANUALLY VENTILATED AND PLACED ON AN ALTERNATE VENTILATOR WITHOUT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23289894 ↗
• MalfunctionOct 15, 2025No Flow; No Flow

  IT WAS REPORTED BY THE CHINA FOOD AND DRUG ADMINISTRATION (CFDA), ADVERSE REACTION EVENT CENTER OF SHANGHAI, AND NOT REPORTED DIRECTLY TO MEDTRONIC BY THE CUSTOMER THAT WHILE IN USE ON A PATIENT, THE 840 VENTILATOR EMITTED A CONTINUOUS "BEEPING" ALARM FOLLOWED BY THE SCREEN DISPLAYING A HARDWARE ERROR INDICATING THAT THE BREATH DELIVERY (BD) BOARD COMMUNICATION HAD A "FAILURE" AND THE VENTILATION STOPPED. THE PATIENT'S OXYGEN SATURATION (O2) DROPPED FROM 96% TO 82%, THE HEART RATE INCREASED TO 130 BEATS PER MINUTE, AND THE LIPS BECAME CYANOTIC. IMMEDIATELY SWITCHED TO MANUAL VENTILATION WITH A RESUSCITATOR BAG, THEN THE OXYGEN SATURATION GRADUALLY INCREASED TO 94%. THE PATIENT WAS PLACED ON AN ALTERNATE VENTILATOR AND THE VITAL SIGNS WERE STABILIZED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 23286501 ↗
• MalfunctionAug 22, 2025No Flow; No Flow

  IT WAS REPORTED BY THE CHINA FOOD AND DRUG ADMINISTRATION (CFDA), ADVERSE REACTION EVENT CENTER OF SHANGHAI, AND NOT REPORTED DIRECTLY TO MEDTRONIC BY THE CUSTOMER THAT THE PB840 VENTILATOR DISPLAYED A HARDWARE ALARM (BAD EXPIRATORY FLOW), INDICATING LOSS OF VENTILATION, AFTER IT WAS CONNECTED TO THE PATIENT. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR, AND THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22876883 ↗
• MalfunctionAug 14, 2025No Flow; No Flow

  IT WAS REPORTED BY THE CHINA FOOD AND DRUG ADMINISTRATION (CFDA), ADVERSE REACTION EVENT CENTER OF SHANGHAI, AND NOT REPORTED DIRECTLY TO MEDTRONIC BY THE CUSTOMER, THAT WHILE IN USE ON A PATIENT THE PB840 VENTILATOR MADE A "BEEP" SOUND ALARM INDICATING LOSS OF VENTILATION. THE PATIENT WAS MANUALLY VENTILATED AND WAS TRANSFERRED TO AN ALTERNATE VENTILATOR WITHOUT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22811311 ↗
• MalfunctionJul 31, 2025No Flow; No Flow

  IT WAS REPORTED BY THE CHINA FOOD AND DRUG ADMINISTRATION (CFDA) AND THE ADVERSE REACTION EVENT CENTER OF SHANGHAI, AND NOT DIRECTLY BY THE CUSTOMER TO MEDTRONIC, THAT WHILE IN USE ON A PATIENT, THE PB840 VENTILATOR GENERATED A "HARDWARE ERROR" AND WAS UNABLE TO VENTILATE. 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 22679371 ↗
• MalfunctionFeb 3, 2025No Flow; No Flow

  IT WAS REPORTED BY (B)(6), AND NOT REPORTED DIRECTLY TO MEDTRONIC BY THE CUSTOMER, WHILE IN USE ON A PATIENT, THIS 840 VENTILATOR GENERATED A SYSTEM ERROR AND THE UNIT "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 21293482 ↗
• MalfunctionJan 31, 2025Defective Alarm; Infusion or Flow Problem; Defective Alarm; Infusion or Flow Problem

  IT WAS REPORTED BY THE CHINA FOOD AND DRUG ADMINISTRATION (CFDA), ADVERSE REACTION EVENT CENTER OF SHANGHAI, AND NOT REPORTED DIRECTLY TO MEDTRONIC BY THE CUSTOMER, WHILE IN USE ON A PATIENT, THE ACTUAL TIDAL VOLUME OF THIS 840 VENTILATOR WAS DIFFERENT FROM THE SET VALUE AND THE VENTILATOR DID NOT ALARM AND THE "EXHALATION LOOP" COULD NOT BE CLOSED. 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 21284865 ↗
• MalfunctionJan 30, 2025No Flow; No Flow

  IT WAS REPORTED BY THE CHINA FOOD AND DRUG ADMINISTRATION (CFDA), ADVERSE REACTION EVENT CENTER OF SHANGHAI, AND NOT REPORTED DIRECTLY TO MEDTRONIC BY THE CUSTOMER THAT WHILE IN USE ON A PATIENT, THE 840 VENTILATOR GENERATED A SAFETY VALVE OPEN (SVO) ERROR. 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 21275387 ↗
• MalfunctionNov 27, 2024No Flow; No Flow

  IT WAS REPORTED BY THE CHINA FOOD AND DRUG ADMINISTRATION (CFDA), ADVERSE REACTION EVENT CENTER OF SHANGHAI, AND NOT REPORTED DIRECTLY TO MEDTRONIC BY THE CUSTOMER, THAT WHILE IN USE ON A PATIENT, THE 840 VENTILATOR SCREEN WENT BLACK AND THE UNIT DID NOT CONTINUE TO DELIVER BREATHS. 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 20802715 ↗
• MalfunctionOct 1, 2024No Flow; No Flow

  IT WAS REPORTED BY THE CHINA FOOD AND DRUG ADMINISTRATION (CFDA), ADVERSE REACTION EVENT CENTER OF (B)(6), AND NOT REPORTED DIRECTLY TO MEDTRONIC BY THE CUSTOMER THAT WHILE IN USE ON A PATIENT, THE 840 VENTILATOR SHUT DOWN. THE PATIENT WAS REMOVED FROM THE VENTILATOR THEN WAS IMMEDIATELY PROVIDED WITH MANUAL AIR AND PLACED ON AN ALTERNATE VENTILATOR WITHOUT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 20346131 ↗
• MalfunctionAug 12, 2024No Flow; No Flow

  IT WAS REPORTED BY THE CHINA FOOD AND DRUG ADMINISTRATION (CFDA), ADVERSE REACTION EVENT CENTER OF SHANGHAI, AND NOT REPORTED DIRECTLY TO MEDTRONIC BY THE CUSTOMER, THAT THE 840 VENTILATOR GENERATED AN ALERT INDICATING "VENTILATOR SYSTEM FAILURE" AND DID NOT CONTINUE DELIVERING BREATHS WHILE THE PATIENT WAS CONNECTED. 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 19962763 ↗
• MalfunctionMar 28, 2024No Flow; No Flow

  IT WAS REPORTED BY THE CHINA FOOD AND DRUG ADMINISTRATION (CFDA), ADVERSE REACTION EVENT CENTER OF SHANGHAI, AND NOT REPORTED DIRECTLY TO MEDTRONIC BY THE CUSTOMER THAT WHILE IN USE ON A PATIENT, THIS 840 VENTILATOR GENERATED A "HARDWARE FAULT ALARM", LOSS OF BD (BREATH DELIVERY) COMMUNICATION DIAGNOSTIC CODE THEN STOPPED OPERATING. THE PATIENT EXPERIENCED DIFFICULTY OF BREATHING WITH A DECREASED OXYGEN SATURATION OF 85%. THE ELECTROCARDIOGRAM (ECG) SHOWED AN ACCELERATED HEART RATE. THE PATIENT WAS MANUALLY VENTILATED WITH A "RESPIRATORY BALLOON" AND PLACED ON AN ALTERNATE VENTILATOR RESULTING IN IMPROVEMENT OF THE PATIENT'S CONDITION AND NO PERMANENT HARM OR INJURY TO THE PATIENT.

  Patient problems: Dyspnea; Low Oxygen Saturation; Tachycardia

  MAUDE report 18994246 ↗
• MalfunctionJan 26, 2024No Flow; No Flow

  IT WAS REPORTED BY THE CHINA FOOD AND DRUG ADMINISTRATION (CFDA), ADVERSE REACTION EVENT CENTER OF SHANGHAI, AND NOT REPORTED DIRECTLY TO MEDTRONIC BY THE CUSTOMER, THAT THE 840 VENTILATOR GENERATED A HARDWARE FAILURE ALARM AND VENTILATION STOPPED 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 18590414 ↗
• MalfunctionDec 27, 2023No Flow; No Flow

  IT WAS REPORTED BY THE CHINA FOOD AND DRUG ADMINISTRATION (CFDA), ADVERSE REACTION EVENT CENTER OF SHANGHAI, AND NOT REPORTED DIRECTLY TO MEDTRONIC BY THE CUSTOMER, THAT WHILE IN USE ON A PATIENT, THIS 840 VENTILATOR GENERATED AN ALARM AND THERE WAS NO VENTILATION. ALTHOUGH REQUESTED, PATIENT OUTCOME AND INTERVENTION ARE UNKNOWN AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 18401331 ↗
• MalfunctionDec 24, 2023No Flow; Output Problem; No Flow; Output Problem

  IT WAS REPORTED THAT THIS 840 VENTILATOR GENERATED A DEVICE ALERT INDICATING BREATH DELIVERY (BD) POWER ON SELF TEST (POST) FAILURE, COULD NOT ACCESS SERVICE MODE AND THE BREATH DELIVERY UNIT (BDU) SERIES NUMBER DISAPPEARED. 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 18389976 ↗
• MalfunctionDec 21, 2023No Flow; No Flow

  IT WAS REPORTED BY THE CHINA FOOD AND DRUG ADMINISTRATION (CFDA), ADVERSE REACTION EVENT CENTER OF SHANGHAI, AND NOT REPORTED DIRECTLY TO MEDTRONIC BY THE CUSTOMER, THAT THE 840 VENTILATOR GENERATED A VENTILATOR HARDWARE ALARM, "FLOW SENSOR FAILURE" ALARM AND DID NOT 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 18372544 ↗
• MalfunctionNov 30, 2023No Flow; No Flow

  IT WAS REPORTED BY THE CHINA FOOD AND DRUG ADMINISTRATION (CFDA), ADVERSE REACTION EVENT CENTER OF SHANGHAI, AND NOT REPORTED DIRECTLY TO MEDTRONIC BY THE CUSTOMER, WHILE IN USE ON A PATIENT, THIS 840 VENTILATOR SHUTDOWN AND STOPPED DELIVERING BREATHS. 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 18241111 ↗