AirLife™ 2K8005Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10190752114159), received between Jan 4, 2021 and Jun 21, 2024 — classified as 1 death, 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jan 10, 2024Open, Classified

   Risk of hypoventilation caused by duckbill and ring broken/disassembled, due to faulty mold/tooling producing out of specification components. Device failure may cause improper ventilation or no ventilation that may result in hypoventilation or hypoxia, and potentially lead to death. The mold/tooling used to produce the affected component was replaced in 2017.

   Z-1061-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• DeathJun 21, 2024Mechanical Problem; Gas/Air Leak; Mechanical Problem; Gas/Air Leak

  RESUSCITATION BAG FAILED. PATIENT EXPIRED.

  Patient problems: Cardiac Arrest; Respiratory Failure

  MAUDE report 19588350 ↗
• MalfunctionMay 10, 2024Mechanical Problem; Mechanical Problem

  RECIEVED A MEDWATCH REPORT FROM FDA STATING THAT THERE WAS A PRODUCT MALFUNCTION WITH A DEVICE THAT WAS INCLUDED IN A PRODUCT RECALL.

  Patient problems: Insufficient Information

  MAUDE report 19294142 ↗
• InjuryMay 10, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE PATIENT EXPERIENCED A DROP IN OXYGEN LEVELS, PROMPTING THE USE OF AN BAG VALVE MASK FOR VENTILATION. HOWEVER, ATTEMPTS TO PROVIDE AIR FAILED EVEN AFTER REPOSITIONING THE PATIENT FOR BETTER AIRWAY ACCESS. SUBSEQUENTLY, THE PATIENT SUFFERED A CARDIAC ARREST, AND A NEW BAG WAS USED AND WORKED APPROPRIATELY. THE PROVIDER WAS ATTEMPTING TO TEST THE BAG, AND HEARD A "POP" WITH THE DEVICE, AND THEN IT FUNCTIONED AFTERWARD.

  Patient problems: Cardiac Arrest; Low Oxygen Saturation

  MAUDE report 16904110 ↗
• InjuryJan 4, 2021Inflation Problem; Inflation Problem

  THE CUSTOMER REPORTED AN ISSUE ON AIRLIFE¿ ADULT MANUAL RESUSCITATOR, 40'' (1.0M) OXYGEN RESERVOIR TUBING, ADULT. PATIENT CODED POST PROCEDURE. THE NURSE STARTED TO BAG THE PATIENT AND THE MANUAL RESUSCITATOR FAILED TO RE-INFLATE AFTER VENTILATION. ANESTHESIA ARRIVED AND NOTED THE DEFECT AND THEY WERE ABLE TO ESTABLISH THE AIRWAY. THE PATIENT CONTINUED TO BE VENTILATED AND EVENTUALLY ESTABLISHED SPONTANEOUS RESPIRATIONS. SHE WAS ADMITTED OVER NIGHT FOR OBSERVATION AND WAS DISCHARGED HOME THE FOLLOWING DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11113405 ↗