AirLife 2002-7Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00607411200014), received between Dec 1, 2022 and Nov 15, 2024 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 15, 2024Leak/Splash; Gas/Air Leak; Leak/Splash; Gas/Air Leak

  WHEN TUBING IS PLACED ON OPTIFLOWS OR TRACH COLLARS THERE IS BACK PRESSURE AND THEY LEAK AROUND THE "COLLAR" OF THE TUBING, WHERE THE TUBING MEETS THE CONNECTOR, AND THEREFORE THE PATIENT IS NOT GETTING THE SET FLOW RATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20700854 ↗
• MalfunctionNov 6, 2024Leak/Splash; Leak/Splash

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 3000219639-2024-00122 FOR THE FIRST REPORT. REFER TO 3000219639-2024-00123 FOR THE SECOND REPORT. BACK PRESSURE WAS REPORTED, WHEN THE TUBING WAS PLACED ON THE OPTIFLOWS AND/OR TRACH COLLARS, AND LEAKING AROUND THE COLLAR OF THE TUBING WHERE THE TUBING MEETS THE CONNECTOR WAS NOTED. IT WAS ADDITIONALLY REPORTED, DURING THE EVENT, THE PATIENT DID NOT RECEIVE THE SET FLOW RATE; THE DEVICE WAS REPLACED, THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 20621855 ↗
• MalfunctionNov 6, 2024Gas/Air Leak; Gas/Air Leak

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 3000219639-2024-00123 FOR THE SECOND REPORT, REFER TO 3000219639-2024-00124 FOR THE THIRD REPORT. BACK PRESSURE WAS REPORTED, WHEN THE TUBING WAS PLACED ON THE OPTIFLOWS AND/OR TRACH COLLARS, AND LEAKING AROUND THE COLLAR OF THE TUBING WHERE THE TUBING MEETS THE CONNECTOR WAS NOTED. IT WAS ADDITIONALLY REPORTED, DURING THE EVENT, THE PATIENT DID NOT RECEIVE THE SET FLOW RATE; THE DEVICE WAS REPLACED, THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 20621462 ↗
• MalfunctionNov 6, 2024Leak/Splash; Leak/Splash

  SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 3000219639-2024-00122 FOR THE FIRST REPORT. REFER TO 3000219639-2024-00124 FOR THE THIRD REPORT . BACK PRESSURE WAS REPORTED, WHEN THE TUBING WAS PLACED ON THE OPTIFLOWS AND/OR TRACH COLLARS, AND LEAKING AROUND THE COLLAR OF THE TUBING WHERE THE TUBING MEETS THE CONNECTOR WAS NOTED. IT WAS ADDITIONALLY REPORTED, DURING THE EVENT, THE PATIENT DID NOT RECEIVE THE SET FLOW RATE; THE DEVICE WAS REPLACED, THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 20621443 ↗
• MalfunctionFeb 23, 2024Connection Problem; Connection Problem

  CAN'T KEEP TUBING ATTACHED TO OXYGEN BLEED IN STEM FOR ADDING OXYGEN TO CIRCUITS PROVIDING POSITIVE PRESSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18773723 ↗
• InjuryDec 1, 2022Disconnection; Disconnection

  THE CONNECTORS TEND TO SLIP AND BECOME DISCONNECTED EASILY. PATIENTS ARE HAVING DESATURATIONS WHILE ON HIGH FLOW OXYGEN DEVICES AND CPAP DEVICES DUE TO THE DISCONNECTION.

  Patient problems: Low Oxygen Saturation

  MAUDE report 15900753 ↗