DAR 331/5661Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20884522034712), received between Dec 23, 2025 and Mar 31, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Crack” (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.

• MalfunctionMar 31, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE NURSE ROUTINELY REPLACED THE BREATHING CIRCUIT AND VENTILATOR TUBING. ONE HOUR LATER, THE BEDSIDE NURSE DISCOVERED CONDENSATE LEAKING FROM THE CONNECTION BETWEEN THE BREATHING CIRCUIT AND THE ENDOTRACHEAL TUBE, INDICATING POOR SEALING AT THE INTERFACE. THE BREATHING CIRCUIT WAS IMMEDIATELY REPLACED. PATIENT OUTCOME WAS ASKED BUT UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 24746261 ↗
• MalfunctionDec 23, 2025Crack; Crack

  IT WAS REPORTED THAT DURING USE, A LOW TIDAL VOLUME ALARM WAS TRIGGERED AND THE PRESET VALUE COULD NOT BE REACHED. THE VITAL SIGNS DID NOT CHANGE MUCH, BUT THE BLOOD OXYGEN WAS A LITTLE LOW FOR ABOUT 20 MINUTES. AN URGENT INSPECTION OF THE VENTILATOR AND THE ENTIRE CIRCUIT REVEALED AN INTERNAL CRACK AT THE INNER LAYER OF THE DOUBLE INTERFACE OF THE BREATHING CIRCUIT. THE DEVICE WAS IMMEDIATELY REPLACED.

  Patient problems: Hypoventilation

  MAUDE report 23885464 ↗