Portex 100/133/080Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15019315020377), received between Oct 31, 2020 and Nov 1, 2022 — classified as 3 malfunctions.

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 16, 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.

• MalfunctionNov 1, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT ON A SURGICAL TRACHEOSTOMY OF AN INTENSIVE CARE PATIENT, BEFORE MAKING AN INCISION IN THE TRACHEA, THE OUTER LEG IS ALWAYS CHECKED ACCORDING TO ROUTINE. DURING THIS CHECK, NO HOOD LEAKAGE WAS DETECTED WITHOUT EXTERNAL INFLUENCE, I.E. THE CUFF WAS NOT BROKEN BEFORE. ADDITIONAL INFORMATION RECEIVED VIA CUSTOMER RESPONSE EMAIL 12-OCT-2022: PRODUCT FAULT IS FOR A LEAK. RESOLVED USING A NEW TUBE SIZE 7. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15709917 ↗
• MalfunctionNov 1, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT ON A SURGICAL TRACHEOSTOMY OF AN INTENSIVE CARE PATIENT, BEFORE MAKING AN INCISION IN THE TRACHEA, THE OUTER LEG IS ALWAYS CHECKED ACCORDING TO ROUTINE. DURING THIS CHECK, NO HOOD LEAKAGE WAS DETECTED WITHOUT EXTERNAL INFLUENCE, I.E. THE CUFF WAS NOT BROKEN BEFORE. ADDITIONAL INFORMATION RECEIVED VIA CUSTOMER RESPONSE EMAIL 12-OCT-2022: PRODUCT FAULT IS FOR A LEAK. RESOLVED USING A NEW TUBE SIZE 7. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15709867 ↗
• MalfunctionOct 31, 2020Inflation Problem; Inflation Problem

  LOT NUMBERS REVEALED IN ADDITIONAL INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10767625 ↗