Portex 100/179/065Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15019315022111), received between Jun 21, 2021 and Oct 2, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Deflation Problem” (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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 2, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT ON 10-AUG-2023 AFTER THE TRACHEAL INTUBATION WAS REMOVED THE PATIENT WAS UNABLE TO COUGH UP THE PHLEGM, HAD SHORTNESS OF BREATH AND DECREASED PERIPHERAL BLOOD OXYGEN SATURATION. NASOTRACHEAL INTUBATION WAS SUCCESSFUL UNDER THE GUIDANCE OF A FIBEROPTIC BRONCHOSCOPE. AFTERWARDS THERE WAS A SOUND OF AIR LEAKAGE THAT COULD BE HEARD AND THERE WAS A BIG DIFFERENCE BETWEEN THE INHALED AND EXHALED TIDAL VOLUMES OF THE VENTILATOR. THE TRACHEAL TUBE WAS IMMEDIATELY PULLED OUT AND REPLACED WITH A NEW TRACHEAL TUBE.

  Patient problems: Low Oxygen Saturation; Pleural Effusion

  MAUDE report 17855564 ↗
• InjuryMay 2, 2023Deflation Problem; Unintended Deflation; Deflation Problem; Unintended Deflation

  IT WAS REPORTED THAT THE PATIENT WAS HYPOXIC. A DOCTOR DID A BEDSIDE NASAL TRACHEAL INTUBATION AND NO ISSUES WERE FOUND. AFTER ONE HOUR IN USE, THE CUFF WAS DEFLATED SIGNIFICANTLY. NO PATIENT HARM WAS REPORTED.

  Patient problems: Hypoxia

  MAUDE report 16856363 ↗
• MalfunctionJun 21, 2021Gel Leak; Gel Leak

  INFORMATION RECEIVED A SMITHS MEDICAL INTUBATION/PORTEX ENDOTRACHEAL TUBES WAS INVOLVED IN A EVENT WITH NASAL INTUBATION WHEN THE BLADDER WAS FOUND TO LEAK, EVENT THOUGH CHECKED TWICE. NO PATIENT ADVERSE EVENTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12033329 ↗