N/A 16SOFT-4Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00607411915833), received between Dec 29, 2022 and Mar 10, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Incomplete or Inadequate Connection” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2026Incomplete or Inadequate Connection

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF THREE REPORTS. REFER TO 3000219639-2026-00002 FOR THE SECOND REPORT. REFER TO 3000219639-2026-00003 FOR THE THIRD REPORT. IT WAS REPORTED, THE AIR-LINE CAME APART WHICH CAUSED THE PATIENT TO NOT RECEIVE OXYGEN. THERE WAS NO REPORT OF HARM OR INJURY AS A RESULT OF THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24559590 ↗
• MalfunctionMar 10, 2026Incomplete or Inadequate Connection

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE THIRD OF THREE REPORTS. REFER TO 3000219639-2026-00001 FOR THE FIRST REPORT. REFER TO 3000219639-2026-00002 FOR THE SECOND REPORT. IT WAS REPORTED, THE AIR-LINE CAME APART WHICH CAUSED THE PATIENT TO NOT RECEIVE OXYGEN. THERE WAS NO REPORT OF HARM OR INJURY AS A RESULT OF THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24559589 ↗
• MalfunctionMar 10, 2026Incomplete or Inadequate Connection

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF THREE REPORTS. REFER TO 3000219639-2026-00001 FOR THE FIRST REPORT. REFER TO 3000219639-2026-00003 FOR THE THIRD REPORT. IT WAS REPORTED, THE AIR-LINE CAME APART WHICH CAUSED THE PATIENT TO NOT RECEIVE OXYGEN. THERE WAS NO REPORT OF HARM OR INJURY AS A RESULT OF THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24559588 ↗
• MalfunctionSep 17, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED: BOTH TIPS OF THE NASAL PRONG ARE FULLY ATTACHED, MAKING VISUAL CONFIRMATION DIFFICULT. HOWEVER, WHEN THE EQUIPMENT IS CONNECTED, FLOW IS BLOCKED, AND FLOW MEASUREMENT IS NOT POSSIBLE.

  Patient problems: Insufficient Information

  MAUDE report 23078216 ↗
• MalfunctionMay 24, 2024Defective Device; Defective Device

  PIN HOLES IN CANNULA TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19397867 ↗
• InjuryMar 1, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  SKIN ALLERGY (REDNESS AND SHARP HEATING OF THE SKIN OF THE FACE) NOT RELIEVED BY ANTIHISTAMINES BUT WITH CORTISONE AFTER 3 DAYS - AS SOON AS THE GLASSES ARE PUT ON, THE TINGLING WARNING OF THE ALLERGY STARTS AGAIN - BY CHANGING GLASSES NO REAPPEARANCE - NO DIETARY, MEDICATION OR COSMETIC CHANGES.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 18822871 ↗
• MalfunctionNov 22, 2023Leak/Splash; Leak/Splash

  CANNULAS ARE LEAKING.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18196861 ↗
• MalfunctionDec 29, 2022Connection Problem; Connection Problem

  THE CANULA CAME OFF AT THE CONNECTION WHILE PATIENT WAS TRAVELING.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 16070724 ↗