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AirLife™ 5504BRecalls & reported problems

Airlife · AirLife™ baby safe flow-inflating resuscitation device 1/2 Liter Bag · Class 2

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10190752145894), received between Oct 16, 2021 and Oct 16, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Pressure Problem” (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

  • Pressure Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionOct 16, 2021Pressure Problem; Pressure Problem

    THE CUSTOMER REPORTED THAT THE BABY SAFE HYP INF, 5L, 60CMH20, MANO NRPR EXPERIENCED MANOMETER WAS STUCK, NOT ALLOWING THE BAG TO REFILL PROPERLY. AS OF THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12643816 ↗

Other VENTILATOR, NON-CONTINUOUS (RESPIRATOR) devices

All VENTILATOR, NON-CONTINUOUS (RESPIRATOR) devices →

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