Puritan Bennett 4-840120DICU-ENRecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10884521076877), received between Apr 3, 2018 and Oct 28, 2024 — classified as 13 malfunctions.

The most frequently reported specific device problem is “No Flow” (10 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2024No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE 840 VENTILATOR GENERATED A RED ALARM AND MULTIPLE VENTILATOR INOPERATIVE MESSAGES. THE PATIENT WAS MANUALLY VENTILATED AND TRANSFERRED TO AN ALTERNATE VENTILATOR WITHOUT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20551729 ↗
• MalfunctionSep 23, 2022No Flow; No Flow

  IT WAS REPORTED BY HEALTH CANADA, THAT WHILE IN USE ON A PATIENT, THIS 840 VENTILATOR SHUT OFF. THE UNIT WOULD NOT TURN BACK ON AND KEPT ALARMING. THE PATIENT OUTCOME AND INTERVENTION WERE NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15472817 ↗
• MalfunctionSep 23, 2022No Flow; No Flow

  IT WAS REPORTED BY HEALTH CANADA, THAT WHILE IN USE ON THE PATIENT, THE 840 VENTILATOR SHUT OFF AND STOPPED FUNCTIONING. 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 15472780 ↗
• MalfunctionFeb 14, 2022No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE (B)(4) VENTILATOR SHUT 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 13529654 ↗
• MalfunctionNov 22, 2021No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS 840 VENTILATOR SHUTS DOWN AFTER 20 MINUTES UPON START UP AND DID NOT ALARM PRIOR TO TURNING OFF. ADDITIONALLY, IT WAS REPORTED THAT THE VENTILATOR SUBSEQUENTLY STARTED BACK ON ITS OWN. THE PATIENT WAS TRANSFERRED TO AN ALTERNATE VENTILATOR WITHOUT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12853022 ↗
• MalfunctionOct 9, 2021No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THIS 840 VENTILATOR POWERED DOWN  AND STOPPED VENTILATING. IT REMAINED OFF FOR APPROXIMATELY FIVE SECONDS AND STARTED BACK UP ON ITS OWN AND THEN IT HAPPENED AGAIN AFTER FOUR MINUTES. 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 12602273 ↗
• MalfunctionFeb 14, 2019No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE 840 VENTILATOR GENERATED A SYSTEM FAILURE AND A "NOT VENTILATED PATIENT" ALARM. THE UNIT HAD GENERATED SEVERAL ERROR CODES WHICH RENDERED THE UNIT INOPERATIVE. THE PATIENT WAS PLACED ON AN ALTERNATE VENTILATOR WITHOUT HARM OR INJURY.

  Patient problems: No Code Available

  MAUDE report 8341737 ↗
• MalfunctionOct 5, 2018No Flow; No Flow

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE 840 VENTILATOR ALARMED AND GENERATED AN ERROR CODE WHICH RENDERED THE UNIT INOPERABLE. THE PATIENT WAS PLACED ON AN ALTERNATE VENTILATOR AND THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE EVENT.

  Patient problems: No Code Available

  MAUDE report 7940491 ↗
• MalfunctionSep 7, 2018No Flow; No Flow

  IT WAS REPORTED THAT DURING PATIENT USE THE 840 VENTILATOR GENERATED A HIGH ALARM, THE SCREEN WENT BLANK AND VENTILATION STOPPED. THE PATIENT WAS MANUALLY VENTILATED VIA AN AMBU BAG AND PLACED ON AN ALTERNATE VENTILATOR. THERE WAS NO PATIENT HARM OR INJURY AS A RESULT OF THE REPORTED EVENT. THE CUSTOMER'S RESPIRATORY THERAPIST EVALUATED THE VENTILATOR. UPON TURNING THE VENTILATOR ON, THE VENTILATOR ALARMED AND MESSAGE SHOWED "NEEDS SERVICE".

  Patient problems: No Code Available

  MAUDE report 7855391 ↗
• MalfunctionAug 17, 2018No Flow; No Flow

  IT WAS REPORTED THAT DURING USE THE 840 VENTILATOR DISPLAY WAS BLANK AND THE VENTILATOR "GOT TURNED OFF". THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR. THE PATIENT'S BLOOD PRESSURE AND OXYGEN SATURATION DROPPED AS A RESULT OF THE REPORTED EVENT. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION ON THE PATIENT OUTCOME, TREATMENT (IF APPLICABLE) AND CLARIFICATION OF THE EVENT; HOWEVER, NO ADDITIONAL INFORMATION WAS ABLE TO BE OBTAINED. THE REPORT OF A BLANK GUI DISPLAY AND CODE IDENTIFIED (GUI RESET) IN THE VENTILATOR LOG INDICATES THAT THE VENTILATOR DID NOT STOPPED VENTILATING THE PATIENT.

  Patient problems: Low Blood Pressure/ Hypotension; Low Oxygen Saturation; No Information

  MAUDE report 7793978 ↗
• MalfunctionJul 2, 2018Device Inoperable; Device Inoperable

  IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, THE 840 VENTILATOR GENERATED AN ALARM AND GENERATED ERROR CODES INDICATING POST (POWER ON SELF TEST) FAILURE AND OXYGEN PSOL (PROPORTIONAL SOLENOID) VALVE STUCK OPEN AND RENDERING THE VENTILATOR TO BECOME INOPERATIVE. 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 7656699 ↗
• MalfunctionJun 22, 2018Device Inoperable; Device Inoperable

  IT WAS REPORTED THAT DURING USE WHILE THE REGISTERED NURSE TRIED TO SUCTION THE INLINE CATHETER, THE 840 VENTILATOR BECAME INOPERABLE. THE VENTILATOR HAD BEEN TURNED OFF AND ON AND WAS REPORTED TO STILL BE INOPERATIVE. THE PATIENT WAS BAGGED AND WAS TRANSFERRED TO AN ALTERNATE VENTILATOR. THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE EVENT.

  Patient problems: No Code Available

  MAUDE report 7629977 ↗
• MalfunctionApr 3, 2018Device Inoperable; Device Inoperable

  IT WAS REPORTED THAT DURING USE, THE 840 VENTILATOR SHUTDOWN WITH A BREATH DELIVERY (BD) AUDIO ALARM AND LOSS OF GRAPHIC USER INTERFACE (GUI) LIGHT-EMITTING DIODE (LED) ALERT. THE PATIENT WAS TRANSFERRED TO ANOTHER VENTILATOR AND THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE EVENT.

  Patient problems: No Code Available

  MAUDE report 7393994 ↗