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Pneupac 100/905/360Recalls & reported problems

Icu Medical, Inc. · 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 15019315079207), received between Mar 15, 2022 and Mar 15, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fitting Problem” (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

  • Fitting Problem1

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.

  • MalfunctionMar 15, 2022Fitting Problem; Fitting Problem

    IT WAS REPORTED THAT THE EDGES OF THE BREATHING MASK OF THE CPAP SYSTEM ERE EMPTY, SO THAT AN AIRTIGHT CONNECTION WITH THE FACE COULD NOT BE ACHIEVED. THE MASK WAS SWITCHED TO RESOLVE THE ISSUE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13769555 ↗

Other Attachment, breathing, positive end expiratory pressure devices

All Attachment, breathing, positive end expiratory pressure devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.