N/A 4MSF1-7-6Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00607411946363), received between Mar 25, 2026 and Mar 25, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THERE WERE ISSUES WITH TWO OF THE ORANGE TIPPED ETCO2 NASAL CANNULAS. THE INITIAL CANNULA PLACED ON THE PATIENT WAS NOT FUNCTIONING. THE EXACT TIME OF PLACEMENT IS UNKNOWN, AND THE LOT NUMBER AND MANUFACTURE DATE FOR THAT UNIT WERE NOT AVAILABLE. THE PRIMARY NURSE NOTED THAT IT HAD NOT BEEN WORKING THROUGHOUT THE DAY. THE NURSE THEN REPLACED IT WITH A NEW CANNULA, WHICH STOPPED FUNCTIONING AFTER APPROXIMATELY 40 MINUTES OF USE. THE PRODUCT WAS BEING USED AT 2 L/MIN O2 ON AN AFEBRILE PATIENT. ALL CONNECTIONS WERE CONFIRMED TO BE SECURE AND PROPERLY ASSEMBLED. AIRLIFE RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 3004748541-2026-00059 FOR FIRST REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24695190 ↗
• MalfunctionMar 25, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THERE WERE ISSUES WITH TWO OF THE ORANGE TIPPED ETCO2 NASAL CANNULAS. THE INITIAL CANNULA PLACED ON THE PATIENT WAS NOT FUNCTIONING. THE EXACT TIME OF PLACEMENT IS UNKNOWN, AND THE LOT NUMBER AND MANUFACTURE DATE FOR THAT UNIT WERE NOT AVAILABLE. THE PRIMARY NURSE NOTED THAT IT HAD NOT BEEN WORKING THROUGHOUT THE DAY. THE NURSE THEN REPLACED IT WITH A NEW CANNULA, WHICH STOPPED FUNCTIONING AFTER APPROXIMATELY 40 MINUTES OF USE. THE PRODUCT WAS BEING USED AT 2 L/MIN O2 ON AN AFEBRILE PATIENT. ALL CONNECTIONS WERE CONFIRMED TO BE SECURE AND PROPERLY ASSEMBLED. AIRLIFE RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 3004748541-2026-00060 FOR SECOND REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24695158 ↗