AirLife™ 2K8010Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10190752114258), received between Oct 25, 2022 and Oct 25, 2022 — classified as 1 death.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• DeathOct 25, 2022Crack; Leak/Splash; Crack; Leak/Splash

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE PEDIATRIC PATIENT ARRIVED PULSELESS AND NOT BREATHING. THE PATIENT WAS MANUALLY VENTILATED AND IT WAS NOTICED THAT IT WAS HARD TO VENTILATE BUT ALSO FELT AN AIR LEAK WHEN COMPRESSING THE 2K8010 - RESUS, INF W/MASK, 40" TBG,P/O, 6/CS. THEY FOUND THE OXYGEN ATTACHMENT STEM NEAR THE ELBOW FOR THE PATIENT INTERFACE WAS CRACKED OFF. THE CUSTOMER HELD HER THUMB OVER THE LEAK AND REQUESTED ANOTHER RESUSCITATION BAG. THE REPLACEMENT BAG PROVIDED TO HER HAD THE SAME PROBLEM. THE THIRD BAG PROVIDED WAS INTACT AND FUNCTIONING CORRECTLY. FOLLOWING THIS EVENT, SHE FOUND ANOTHER RESUSCITATION BAG WITHIN THE ED (EMERGENCY DEPARTMENT) WITH A CRACKED OXYGEN STEM.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15671238 ↗