DAR 444SP02014 (UDI 10884521810785)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521810785), received between Jan 17, 2024 and Mar 1, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 1, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, AN AIR LEAK WAS HEARD IN THE INTUBATION TUBE. OBSERVATION OF THE DEVICE REVEALED THAT THE CLOSED SYSTEM WAS BROKEN ON THE RESPIRATOR SIDE. THE SYSTEM WAS CHANGED IMMEDIATELY AND FIVE MINUTES AFTER FITTING THE NEW CLOSED SYSTEM, THE SAME PROBLEM WAS NOTED WITH A LEAK. WHEN THE CLOSED SYSTEM WAS REPLACED WITH A HYPOXEMIC CONNECTOR, THE CLOSED SYSTEM BROKE, CRUMBLING INTO THE VENTILATOR CIRCUIT AND MAKING IT IMPOSSIBLE TO RECONNECT THE PATIENT AND VENTILATE. THE DOCTOR HAD TO INTERVENE URGENTLY, AND THE PATIENT WAS VENTILATED USING A BAVU (SELF-FILLING BALLOON WITH ONE-WAY VALVE). THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 18817963 ↗
• InjuryMar 1, 2024Crack; Crack

  ACCORDING TO THE REPORTER, AN AIR LEAK WAS HEARD IN THE INTUBATION TUBE. OBSERVATION OF THE DEVICE REVEALED THAT THE CLOSED SYSTEM WAS BROKEN ON THE RESPIRATOR SIDE. THE SYSTEM WAS CHANGED IMMEDIATELY AND FIVE MINUTES AFTER FITTING THE NEW CLOSED SYSTEM, THE SAME PROBLEM WAS NOTED WITH A LEAK. WHEN THE CLOSED SYSTEM WAS REPLACED WITH A HYPOXEMIC CONNECTOR, THE CLOSED SYSTEM BROKE, CRUMBLING INTO THE VENTILATOR CIRCUIT AND MAKING IT IMPOSSIBLE TO RECONNECT THE PATIENT AND VENTILATE. THE DOCTOR HAD TO INTERVENE URGENTLY, AND THE PATIENT WAS VENTILATED USING A BAVU (SELF-FILLING BALLOON WITH ONE-WAY VALVE). THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Hypoventilation

  MAUDE report 18817900 ↗
• MalfunctionJan 17, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE BREATHING SYSTEM SUCTION HAD AIR LEAKAGE IN THE CONNECTION BETWEEN THE SYSTEM AND THE SWIVEL CONNECTOR DURING USE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18527382 ↗