Medline CPRM4416FPMRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10193489019049), received between Mar 4, 2026 and Mar 7, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Gas/Air Leak” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 7, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE RESUSCITATION BAG WAS LEAKING AIR, WITH THE OXYGEN AREA INTERMITTENTLY POPPING OFF THE BACK, RESULTING IN INADEQUATE OXYGEN DELIVERY DURING RESUSCITATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24539797 ↗
• InjuryMar 4, 2026Leak/Splash

  ACCORDING TO THE FACILITY, "CODE BLUE ED THERAPIST WAS BAGGING PATIENT HEARD A LOUD SWISHING NOISE PATIENT O2 SAT STARTED DROPPING. SWITCHED OUT BAG AND O2 SAT STARTING RISING"

  Patient problems: Respiratory Insufficiency

  MAUDE report 24513317 ↗