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DeVilbiss DV54UK-PRecalls & reported problems

Devilbiss Healthcare LLC · SLEEP CUBE AUTO PLUS UK · 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 00885304000051), received between Feb 2, 2018 and Feb 2, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Smoking” (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

  • Smoking1

Patient problems

  • Irritation1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 2, 2018Smoking; Smoking

    DEVILBISS HEALTHCARE'S (B)(4) DISTRIBUTOR REPORTED A CPAP UNIT, MODEL DV54UK-P, MALFUNCTIONED AND "CAUSED MINOR RESPIRATORY IRRITATION TO THE PATIENT". PATIENT ARRIVED AT THE HOSPITAL WITH HIS CPAP UNIT BUT THERE WAS NO INDICATION OF THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE (B)(6) DISTRIBUTOR STATED THE PATIENT REPORTED "THE CPAP UNIT HAD STOPPED FUNCTIONING AND SMOKE STARTED TO COME OUT THROUGH THE MASK. IT WAS AT THIS POINT THE CPAP DEVICE STOPPED WORKING".

    Patient problems: Irritation

    MAUDE report 7237597 ↗

Other Ventilator, Non-Continuous (Respirator) devices

All Ventilator, Non-Continuous (Respirator) devices →

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