Aintree G10789Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002107892), received between Jan 3, 2020 and Jan 3, 2020 — classified as 1 death.

The most frequently reported specific device problem is “Off-Label Use” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• DeathJan 3, 2020Off-Label Use; Off-Label Use

  IT WAS INITIALLY REPORTED THAT THE CUSTOMER HAD "AN INCIDENT" WITH AN AINTREE INTUBATION CATHETER. THE INCIDENT WAS WITH THE CATHETER, WHICH WAS REPORTED TO HAVE BEEN "PUT [THROUGH] A TRACHEOTOMY STOMA" AND THEN "JET VENTILATED". ADDITIONAL INFORMATION CONFIRMED THAT THE DEVICE WAS "USED TO AID WITH A TRACHEOSTOMY CHANGE IN THEATRE". A MANUJET VENTILATION DEVICE WAS ATTACHED TO THE CATHETER VIA A RAPID-FIT ADAPTER (WHICH IS SUPPLIED WITH THE AINTREE INTUBATION CATHETER). JET VENTILATION WAS USED WHILE THE NEW TRACHEAL TUBE WAS INSERTED. THE PATIENT WAS THEN REPORTED TO HAVE COUGHED. IMMEDIATELY, THE PATIENT DETERIORATED AND SUFFERED FROM BILATERAL PNEUMOTHORAXES AND CARDIAC ARREST. BILATERAL NEEDLE DECOMPRESSIONS AND SUBSEQUENT CHEST DRAIN INSERTIONS LED TO THE RETURN OF CIRCULATION. HOWEVER, THE PATIENT ULTIMATELY HAD A SEVERE HYPOXIC BRAIN INJURY AND DIED A FEW WEEKS FOLLOWING THE EVENT. THE CAUSE OF THE SEVERE HYPOXIC BRAIN INJURY AND DEATH IS UNCONFIRMED AT THIS TIME. ADDITIONAL INFORMATION REGARDING THE PATIENT, EVENT, AND DEVICE HAS BEEN REQUESTED BUT IS UNAVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Brain Injury; Cardiac Arrest; Death; Hypoxia; Pneumothorax

  MAUDE report 9547482 ↗