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AirLife 2K8038Recalls & reported problems

Carefusion Corporation · Infant Manual Resuscitator; 40"(1.0m) Oxygen Resevoir Tubing, PEEP Valve, Infant Mask, Pressure Limiting Valve with lock · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885403103155), received between May 14, 2020 and May 14, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Disconnection” (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

Device problems

  • Disconnection1

Patient problems

  • Bradycardia1
  • Low Oxygen Saturation1

Recent adverse event reports

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

  • InjuryMay 14, 2020Disconnection; Disconnection

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE NEONATAL RESUSCITATOR BAG USED TO VENTILATE PATIENT IN THE EMERGENCY DEPARTMENT DURING INTUBATION HAD A MANUFACTURER'S DEFECT WHERE THE HIGH PRESSURE O2 TUBING DISCONNECTED INSIDE THE LARGE BORE TUBING. THIS EVENT OCCURRED WHILE CONNECTED TO A PREMATURE PATIENT AND THIS LEAD TO DESATURATION AND BRADYCARDIA, COMPRESSION INITIATED FOR ONE MINUTE AND THE PATIENT WAS TRANSFERRED TO ANOTHER PEDIATRIC RESUSCITATOR BAG AND THE PATIENT'S HEART RATE AND SPO2 BACK TO NORMAL.

    Patient problems: Bradycardia; Low Oxygen Saturation

    MAUDE report 10058079 ↗

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.