Pneupac P300NUSRecalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 35019315107270), received between Aug 9, 2020 and Mar 18, 2026 — classified as 44 malfunctions.

The most frequently reported specific device problem is “Failure to Cycle” (20 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2026Break; Failure to Cycle

  IT WAS REPORTED THAT THE VENTILATOR WAS NOT CYCLING BREATHS AND THE RELIEF ALARM PRESSURE KNOB WAS BROKEN OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24626729 ↗
• MalfunctionFeb 24, 2026Decrease in Pressure

  IT WAS REPORTED THAT THE DEVICE HAD TRIGGERED A LOW-PRESSURE ALARM, AND DESPITE TRYING DIFFERENT TUBING, THE SAME ALARM HAD CONTINUED. IT WAS ALSO REPORTED THAT THE FRONT PANEL HAD A CRACK AND THE BATTERY DOOR HAD ALSO SUSTAINED CRACKS. THE EVENT HAD OCCURRED DURING SETUP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24433821 ↗
• MalfunctionMay 1, 2025Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT THE DEVICE'S PATIENT PRESSURE CYCLING CHECK FAILED. NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21944592 ↗
• MalfunctionFeb 11, 2025Failure to Cycle; Pressure Problem; Failure to Cycle; Pressure Problem

  IT WAS REPORTED THAT THE DEVICE WAS NOT COMPLETING THE FULL CYCLE AND DISPLAYED A LOW-PRESSURE ERROR. NO ADDITIONAL INFORMATION IS KNOWN.

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

  MAUDE report 21358642 ↗
• MalfunctionFeb 3, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE UNIT WAS LEAKING. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21294381 ↗
• MalfunctionJan 30, 2025Device Alarm System; Decrease in Pressure; Device Alarm System; Decrease in Pressure

  IT WAS REPORTED THAT THE UNIT WAS ALARMING INDICATING LOW PRESSURE ERROR. THERE WAS UNKNOWN PATIENT HARM OR ADVERSE EVENTS DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21276831 ↗
• MalfunctionDec 31, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS A SOUND OF OXYGEN LEAKING FROM THE AIR OUTLET WHEN OXYGEN PRESSURE WAS APPLIED. THE FAULT OCCURRED WHILE CHECKING BEFORE IN USE WITH THE PATIENT. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21047956 ↗
• MalfunctionSep 30, 2024Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT DEVICE FRONT COVER WAS DAMAGED, AND THE TIDAL VOLUME WAS SET TO 500ML BUT TESTED AT 635ML. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20337743 ↗
• MalfunctionAug 27, 2024Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE VENTILATION RATES ARE DIFFERENT. THE ISSUE OCCURRED DURING INSPECTION AND THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20079553 ↗
• MalfunctionAug 8, 2024Complete Loss of Power; Complete Loss of Power

  IT WAS REPORTED THAT THE UNIT TURNED OFF DURING THE PROCEDURE ON THE PATIENT. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19939752 ↗
• MalfunctionJul 16, 2024Failure to Cycle; Failure to Cycle

  IT WAS REPORTED THAT WITH THE DEVICE THERE WAS A CONTINUOUS FLOW. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19756708 ↗
• MalfunctionJun 11, 2024Component Missing; Detachment of Device or Device Component; Device Difficult to Maintain; Component Missing; Detachment of Device or Device Component; Device Difficult to Maintain

  IT WAS REPORTED THAT THE DEVICE IS DUE FOR THE ANNUAL PREVENTATIVE MAINTENANCE (PM) AND NEEDS AN ALARM CAP REPLACED. THERE WAS UNKNOWN PATIENT INVOLVEMENT, AND UNKNOWN HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19510825 ↗
• MalfunctionMay 1, 2024Failure to Cycle; Failure to Cycle

  IT WAS REPORTED THAT IN AUGUST 2020, THE VENTILATOR HAD CONTINUOUS CYCLING THAT OCCURRED DURING INSPECTION EVERY MORNING. RESOLVED BY REPEATING ON/OFF. IN SEPTEMBER 2020, IT OCCURRED IMMEDIATELY AFTER PATIENT USE. SWITCH TO BVM. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19220801 ↗
• MalfunctionMar 22, 2024Gas/Air Leak; Noise, Audible; Gas/Air Leak; Noise, Audible

  IT WAS REPORTED THAT THE VENTILATOR HAD A LONG INTAKE TIME AND PRODUCED AN OXYGEN LEAK NOISE. THE FAULT OCCURRED DURING THE PRE-USE CHECK. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18960963 ↗
• MalfunctionNov 8, 2023Loose or Intermittent Connection; Incomplete or Inadequate Connection; Loose or Intermittent Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT DURING THE MAINTENANCE CHECK UP, GSO ENGINEER NOTICED THE OUTLET WAS TIGHTENED WITH THE TORQUE OF 4.5N OR SMALLER. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18095199 ↗
• MalfunctionAug 4, 2023Loose or Intermittent Connection; Detachment of Device or Device Component; Key or Button Unresponsive/not Working; Loose or Intermittent Connection; Detachment of Device or Device Component; Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE DEVICE WAS MISSING THE RELIEF ALARM PRESSURE KNOB AND THE CAP WAS LOOSE ON THE FRONT FACE PLATE. PATIENT INVOLVEMENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17459858 ↗
• MalfunctionFeb 20, 2023Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE DEVICE WOULD NOT TURN ON. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT, NO OBSERVABLE CLINICAL SYMPTOMS, OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

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

  MAUDE report 16406117 ↗
• MalfunctionFeb 6, 2023Defective Alarm; Defective Alarm

  IT WAS REPORTED THAT NONE OF THE VENTILATOR ALARMS ARE WORKING. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

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

  MAUDE report 16306032 ↗
• MalfunctionNov 16, 2022Failure to Cycle; Failure to Cycle

  ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 6-DEC-2022: THE DEVICE WAS REPORTED BROKEN ON 10NOV2022.

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

  MAUDE report 15810281 ↗
• MalfunctionNov 8, 2022Loose or Intermittent Connection; Loose or Intermittent Connection

  ADDITIONAL INFORMATION RECEIVED VIA EMAIL 09-NOV-2022: EVENT DATE UPDATED: (B)(6) 2022. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15755347 ↗
• MalfunctionOct 25, 2022Pressure Problem; Pressure Problem

  ADDITIONAL INFO RECEIVED VIA EMAIL 27-OCT-2022: EVENT DATE:09/26/2022. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15669546 ↗
• MalfunctionSep 12, 2022Failure to Cycle; Noise, Audible; Failure to Cycle; Noise, Audible

  IT WAS REPORTED THAT THERE WERE FLEETING CYCLING ISSUES AND OTHER UNEXPECTED MECHANICAL NOISE ISSUES. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

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

  MAUDE report 15402099 ↗
• MalfunctionSep 12, 2022Device Alarm System; Inaccurate Flow Rate; Device Alarm System; Inaccurate Flow Rate

  ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 12-SEP-2022. THE EVENT DATE WAS UPDATED. UNKNOWN IF PATIENT WAS INVOLVED.

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

  MAUDE report 15401974 ↗
• MalfunctionSep 7, 2022Failure to Cycle; Noise, Audible; Failure to Cycle; Noise, Audible

  IT IS REPORTED THAT THE DEVICES HAVE BEEN HAVING FLEETING CYCLING ISSUES AND OTHER UNEXPECTED MECHANICAL NOISE ISSUES. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NO FURTHER INFORMATION WAS RECEIVED. NO PATIENT INJURY REPORTED.

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

  MAUDE report 15371705 ↗
• MalfunctionAug 9, 2022Failure to Cycle; Noise, Audible; Failure to Cycle; Noise, Audible

  IT WAS REPORTED THAT THE DEVICES HAVE BEEN HAVING FLEETING CYCLING ISSUES AND OTHER UNEXPECTED MECHANICAL NOISE ISSUES. NO PATIENT INJURY WAS REPORTED.

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

  MAUDE report 15193615 ↗