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AirLife™ 2K8008BRRecalls & reported problems

Airlife · Pediatric Manual Resuscitator 40” (1.0 m) Oxygen Reservoir Tubing, Masks (Toddler, Child, Adult), Pressure Limiting Valve with Lock · 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 10190752149731), received between Aug 26, 2021 and Aug 26, 2021 — classified as 1 malfunction.

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

  • 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.

  • MalfunctionAug 26, 2021Disconnection; Disconnection

    THE CUSTOMER REPORTED THAT AT THE CONNECTION WHERE THE AMBU BAG AND HOSE COME TOGETHER, THE BREATHING TUBES ARE CONNECTING LIKE A FRICTION SLIP AND THE STANDARD IS A LOCK CONNECTION. WITH THE SLIP CONNECT, ANY PRESSURE POPS THE TUBE OUT RENDERING THE DEVICE UNUSABLE. THEY ATTEMPTED TO USE THE SAMPLE ON A PATIENT BUT IT BLEW APART MULTIPLE TIMES. THERE WAS NO HARM REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12370815 ↗

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.