AirLife 2K8004Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10885403170249), received between Mar 2, 2020 and Oct 28, 2020 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (2 reports).

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 18, 2026.

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.

• MalfunctionOct 28, 2020Disconnection; Disconnection

  THE CUSTOMER REPORTED THAT OXYGEN TUBING OF AIRLIFE ADULT MANUAL RESUSCITATOR GOT DISCONNECTED, AND THE BREATHING BAG FELL OFF EASILY. THESE ISSUES WERE DETECTED WHILE CONNECTED TO A PATIENT, BUT NO HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10752081 ↗
• InjuryApr 9, 2020Defective Device; No Pressure; Defective Device; No Pressure

  THE CUSTOMER REPORTED WHILE USING THE AIRLIFE ADULT MANUAL RESUSCITATOR, AN INABILITY TO VENTILATE. ON (B)(6) 2020, THE CUSTOMER REPORTED (B)(6) YEAR OLD FEMALE FROM NURSING HOME BROUGHT IN DUE TO CHOKING AIRWAY CLEARED AND WAS INTUBATED (FOOD VISIBLE BELOW VOCAL CORDS). AFTER EXCHANGING THE BAGS (MANUAL RESUSCITATOR), THE CUSTOMER REPORTED ALTERNATIVE VENTILATION WAS PROVIDED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9946542 ↗
• InjuryApr 9, 2020Defective Device; No Pressure; Defective Device; No Pressure

  THE CUSTOMER REPORTED WHILE USING THE AIRLIFE ADULT MANUAL RESUSCITATOR, AN INABILITY TO VENTILATE. ON (B)(6) 2020, THE REPORTED THE PATIENT (B)(6) YEAR OLD FEMALE BROUGHT INTO ER WITH AGONAL BREATHING. THE CUSTOMER REPORTED THE PATIENT WAS NOT INTUBATED INITIALLY. SHE CODED, THEY BAGGED HER[?] 1ST BREATH WAS GOOD AND THEN LOST PRESSURE AGAIN, SO THEY PULLED THE BACKUP BAG. 2ND BAG DID NOT WORK[?] THERAPIST LEFT ROOM TO RETRIEVE A 3RD BAG WHICH WORKED. WHILE THERAPIST WAS OUT OF THE ROOM, THE ER DOCTOR INTUBATED THE PATIENT. AFTER EXCHANGING THE BAGS (MANUAL RESUSCITATOR), THE CUSTOMER REPORTED ALTERNATIVE VENTILATION WAS PROVIDED TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9946472 ↗
• InjuryMar 2, 2020Material Twisted/Bent; Material Twisted/Bent

  THE CUSTOMER REPORTED THAT THE AIRLIFE ADULT MANUAL RESUSCITATOR EXPERIENCED A DEFECT PROBLEM. IN POST ANESTHESIA CARE UNIT, PATIENT EXPERIENCED DIFFICULTY BREATHING. SO THEY BAGGED THE PATIENT TO CONTINUE BREATHING. BUT DUE TO HOSE AT BASE OF AMBU BAG WAS KINKED OR PINCHED, IT DID NOT ALLOW ADEQUATE OXYGEN TO FLOW INTO THE AMBU BAG. WHEN THE ISSUE OCCURRED, THE PATIENT'S SPO2 WERE NOT COMING UP FROM LOW 80%, ONCE IDENTIFIED STAFF WERE ABLE TO GET LINE OPEN ENOUGH TO BRING PATIENT'S SPO2 UP TO 99%.

  Patient problems: Hypoxia

  MAUDE report 9777287 ↗