Medline Industries, Inc. CPRM1116Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884389125120), received between Apr 2, 2018 and Feb 1, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 1, 2024Inflation Problem; Inflation Problem

  NOT INFLATING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18628109 ↗
• MalfunctionApr 2, 2018Break; Detachment Of Device Component

  IT WAS REPORTED THAT DURING A PATIENT RESUSCITATION EVENT THE SWIVEL PIECE OF THE MASK BAG RESUSCITATOR BROKE OFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7389539 ↗