The BAG II Resuscitator Adult w/mask #5 845111Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07045432067910), received between Feb 8, 2018 and Feb 8, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Activation Failure” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 8, 2018Ambient Temperature Problem; Device Operational Issue; Activation Failure; Ambient Temperature Problem; Device Operational Issue; Activation Failure

  THE PREHOSPITAL SERVICE DEPARTMENT OF A NON-US HOSPITAL REPORTED THE BAG II RESUSCITATOR'S ABILITY TO RE-INFLATE STARTS TO SLOW AT -7 DEGREES CELSIUS AND BY -18 C (DFU, MINIMUM OPERATING TEMP) THE VENTILATION BAG DOES NOT RE-INFLATE AT ALL; AS FOUND DURING THEIR IN-HOUSE TEMPERATURE TESTING. THEY REPORTED THEY HAVE PREVIOUSLY SUBMITTED SEVERAL NONCONFORMANCE REPORTS TO THEIR LOCAL HEALTH AUTHORITIES FOR OTHER PATIENT INCIDENTS (NO DETAILS PROVIDED) BUT DURING THESE TEMPERATURE TESTS NO PATIENT WAS INVOLVED NOR HARMED.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 7251973 ↗