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DeVilbiss DV55D-HHRecalls & reported problems

Devilbiss Healthcare LLC · IntelliPAP Bilevel S w/HH · 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 00885304001973), received between Oct 13, 2021 and Oct 13, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Emits Odor” (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

  • Device Emits Odor1

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.

  • MalfunctionOct 13, 2021Device Emits Odor; Device Emits Odor

    DEVILBISS HEALTHCARE IS THE MANUFACTURER OF THE DEVICE WHICH IS A PORTABLE OXYGEN CONCENTRATOR. WE ARE AWAITING RETURN OF THE DEVICE FOR EVALUATION WE ARE FILING THIS REPORT IN AN OVERABUNDANCE OF CAUTION TO BE TIMELY. A FOLLOW-UP SUBMISSION WILL BE FILED WHEN ADDITIONAL DATA BECOMES AVAILABLE. WHILE IN NORMAL USE THE DEVICE MADE A NOISE AND BEGAN EMITTING A BURNING SMELL. THE USER'S WIFE WOKE HIM UP. THERE WAS NO PATIENT CONSEQUENCE. THE DEVICE IS OUT OF WARRANTY ON JULY 6, 2021.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12628363 ↗

Other Ventilator, Non-Continuous (Respirator) devices

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