Skip to content

AirLife™ 2K8017Recalls & reported problems

Airlife · AirLife™ Manual Resuscitator Variable Volume Oxygen Reservoir Tubing, Adult Mask · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
2
Deaths reported
1
Injuries reported
1
Recalls naming it
1

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10190752114296), received between Jul 17, 2020 and Aug 11, 2023 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Improper Flow or Infusion” (1 report).

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. How this data works · Data updated Oct 13, 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-1064-2024 · Root cause: Process control · FDA record ↗

Most reported problems

Device problems

  • Improper Flow or Infusion1
  • Material Integrity Problem1

Patient problems

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • DeathAug 11, 2023Improper Flow or Infusion; Improper Flow or Infusion

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE RESUS, ADLT W/MASK, LRG TBG, 6/CS HAS FAILED IN PROVIDING AIR TO THE PATIENT. INSTEAD OF PROVIDING AIR THE AMBUBAG WAS GETTING AIR FROM THE PATIENT. THE PATIENT WAS DIED DUE TO THIS FAILURE.

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

    MAUDE report 17506908 ↗
  • InjuryJul 17, 2020Material Integrity Problem; Material Integrity Problem

    THE CUSTOMER REPORTED THAT THE TUBE OF AIRLIFE ADULT MANUAL RESUSCITATOR, VARIABLE VOLUME OXYGEN RESERVOIR TUBING, ADULT MASK COMES OUT AND CANNOT BE REATTACHED. THE ISSUE OCCURRED DURING PATIENT-USE AND THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS REPORTED EVENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10292953 ↗

Other Cardiopulmonary resuscitation aid kit devices

All Cardiopulmonary resuscitation aid kit devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.