Portex 100/890/080Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15019315060397), received between Sep 14, 2023 and Sep 14, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Inflation 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 16, 2026.

Most reported problems

Recent adverse event reports

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

• InjurySep 14, 2023Inflation Problem; Unintended Deflation; Inflation Problem; Unintended Deflation

  IT WAS REPORTED THAT THE BEDSIDE NURSE FOUND THE PATIENT'S TRACHEOSTOMY TUBE CUFF HAD GONE DOWN TO 10CM OF H20 AT THE BEGINNING OF HER SHIFT. SHE NEEDED TO RE-INFLATE IT BACK TO 30CM OF H20. PATIENT WAS INVOLVED, NO PATIENT INJURY OR ADVERSE EFFECTS REPORTED. PATIENT INFORMATION IS NOT AVAILABLE. TRACH TEAM CONSULTANT PERFORMED CUFF PRESSURE CHECK AND RE-INFLATED BACK TO APPROPRIATE LEVEL. CUFF WAS RE-CHECKED AFTER AN HOUR AND LEAK WAS CONFIRMED. PATIENT WAS FASTED AND AN URGENT TRACHEOSTOMY CHANGE WAS PERFORMED BY ICU CONSULTANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17745554 ↗