N/A 79SOFT-7Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00607411915932), received between Oct 7, 2025 and Jul 10, 2026 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (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. How this data works · Data updated Oct 13, 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.

• InjuryJul 10, 2026Fire

  IT WAS REPORTED THAT THE PATIENT INITIALLY STATED THAT, WHILE WEARING OXYGEN AND ATTEMPTING TO WASH THEIR FACE AT A BATHROOM SINK, A SPARK WAS GENERATED BY THE HOT WATER, CAUSING THE OXYGEN TUBING TO IGNITE AND EXPLODE. THE PATIENT LATER RECANTED THIS ACCOUNT AND REPORTED THAT THE INCIDENT OCCURRED WHEN A LIGHTER WAS IGNITED IN CLOSE PROXIMITY TO THE OXYGEN TUBING, ACKNOWLEDGING THAT THE LIGHTER WAS THE SOURCE OF IGNITION. AS A RESULT OF THE EVENT, THE PATIENT WAS HOSPITALIZED AND TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) FOR OBSERVATION AND TREATMENT. THE PATIENT SUSTAINED FIRST- AND SECOND-DEGREE BURNS TO THE FACE, HEAD, AND UPPER CHEST, AS WELL AS NASAL CONGESTION, AND RECEIVED WOUND CARE TREATMENT AND A PLASTIC SURGERY CONSULTATION.

  Patient problems: Partial thickness (Second Degree) Burn; Superficial (First Degree) Burn

  MAUDE report 25782954 ↗
• MalfunctionOct 7, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 3004748541-2025-00076 FOR THE SECOND REPORT. IT WAS REPORTED: FLOW WAS NOT COMING THROUGH THE OUTFLOW OF THE HUMIDIFIER BOTTLE, HOWEVER, THERE WERE BUBBLES, INDICATING FLOW INTO THE BOTTLE, DISCOVERED DURING PATIENT USE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23238988 ↗
• MalfunctionOct 7, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED: FLOW WAS COMING OUT OF THE HUMIDIFIER BOTTLE, BUT MINIMAL FLOW WAS COMING THROUGH THE CANNULA, DISCOVERED DURING USE. NO HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23238987 ↗