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pNeuton miniRecalls & reported problems

Airon Corporation · pNeuton Ventilator, mini · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00853678006023), received between Dec 11, 2015 and Dec 11, 2015.

The most frequently reported specific device problem is “Maintenance Does Not Comply To Manufacturers Recommendations” (1 report).

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

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Maintenance Does Not Comply To Manufacturers Recommendations1
  • Use of Device Problem1

Patient problems

  • Missing Value Reason1
  • No Information1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • Dec 11, 2015Use of Device Problem; Maintenance Does Not Comply To Manufacturers Recommendations; Adverse Event Without Identified Device or Use Problem

    PATIENT WAS BROUGHT TO ANTEROOM OF THE MRI FOR SCAN. CUSTOMARY FOR THE MRI SCAN THE PATIENT WAS INTUBATED IN THE MRI SUITE IMMEDIATELY PRIOR TO THE SCAN. VENTILATION WAS ESTABLISHED USING AN ANESTHESIA MACHINE (DRAEGER) POST INDUCTION/INTUBATION. THE PATIENT SETTINGS WERE PC: PIP 18, PEEP 3, TI 0.7 SEC, WITH RATE OF 30 BPM. MEASURED TIDAL VOLUMES WERE MID 30S WITH APPROPRIATE VITAL SIGNS AND CHEST RISE, MONITORING PETCO2 OF 45 AS REPORTED BY THE RESPIRATORY THERAPIST. THE PNEUTON MINI OPERATIONAL VERIFICATION WAS COMPLETED AT THE BEDSIDE WITHOUT ANY NOTED ERRORS. PNEUTON MINI PATIENT SETTINGS WERE INITIALLY PLACED ON IMV/CPAP: PIP 20, PEEP 5, TI 0.4 SEC, TE 2.0 SEC WITH FLOW RATE 8 LPM. CLINICAL OBSERVATION NOTED A DECREASE IN PATIENT CHEST WALL MOVEMENT AND PETCO2 DROPPED TO 25 WITH ABSENCE OF AN ALVEOLAR PLATEAU. DESPITE MULTIPLY VENTILATOR CHANGES AT THE BEDSIDE; TI SEC, FLOW RATE AND PEEP, THEY WERE UNABLE TO OBTAIN A NORMAL CAPNOGRAPH AND CHEST WALL MOVEMENT REMAINED LESS THAN THE ANESTHESIA MACHINE. A SECOND PNEUTON MINI WAS SET-UP FOR PATIENT APPLICATION, PASSED OPERATIONAL VERIFICATION AND APPLIED THE SAME PATIENT SETTINGS, CHANGES IN DIFFERENT VENTILATOR SETTINGS AS NOTED

    Patient problems: Missing Value Reason; No Information; No Known Impact Or Consequence To Patient

    MAUDE report 5290618 ↗

Other Ventilator, Continuous, Facility Use devices

All Ventilator, Continuous, Facility Use devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.