Portex 100/131/070Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15019315057236), received between Feb 7, 2022 and Sep 27, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Gas/Air Leak” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 27, 2022False Alarm; False Alarm

  IT WAS REPORTED THAT AN OCCLUSION MESSAGES OCCURRED THOUGH ALL THE LINE HAS BEEN CLEARED FROM OBSTRUCTIONS. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15494809 ↗
• InjuryFeb 7, 2022Leak/Splash; Gas/Air Leak; Leak/Splash; Gas/Air Leak

  IT WAS REPORTED THAT, JUST AFTER BRINGING A PATIENT THROUGH TO THEATRE IT WAS NOTICED THAT THERE WAS A LEAK FROM THE PATIENTS ENDO TRACHEAL TUBE. PATIENT REINTUBATED WITH AN ARMOURED TUBE. THERE WAS NO PATIENT INJURY.

  Patient problems: Airway Obstruction; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13472773 ↗
• InjuryFeb 7, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT WHILE UTILIZING THE DEVICE TO SWAP OUT A SEPARATE TRACH TUBE, THE REPORTER NOTED A HOLE LOCATED IN THE BASE OF THE PILOT TUBE. PATIENT WAS REINTUBATED WITH AN ARMOURED TUBE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13472652 ↗