Portex C49201668D-NLRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019315090141), received between Jun 21, 2024 and Jun 24, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Read Input Signal” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE DEVICE FAILED DURING THE ANESTHESIA MACHINE LEAK TEST. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19593672 ↗
• MalfunctionJun 21, 2024Failure to Read Input Signal; Gas/Air Leak; Failure to Read Input Signal; Gas/Air Leak

  IT WAS REPORTED THAT THERE WERE FAILURES DURING THE ANESTHESIA MACHINE TESTING IN MULTIPLE ANESTHESIA BREATHING CIRCUITS. THE FAILED LOT WAS REMOVED AND REPLACED WITH A DIFFERENT LOT NUMBER. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19583533 ↗