DeVilbiss 5650CRecalls & reported problems
Devilbiss Healthcare LLC · PULMO-AIDE CANADA · 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 00885304000884), received between Apr 1, 2024 and Apr 1, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Decrease in Pressure” (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.
Reports received per month
Most reported problems
Device problems
- Decrease in Pressure1
- Smoking1
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.
MalfunctionApr 1, 2024Decrease in Pressure; Smoking; Decrease in Pressure; Smoking
DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A NEBULIZER COMPRESSOR BY A SERVICE PROVIDER, WHO REPORTED THAT THE UNIT HAD LOW PRESSURE DURING USE, SMELLED BURNED AND THAT TREATMENT TIME TOOK TOO LONG. WHEN THE END-USER SAW SMOKE EMITTING FROM THE DEVICE, SHE STOPPED THE DEVICE AND COMPLETED HER TREATMENT WITH HER BACK-UP COMPRESSOR. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. DEVILBISS IS IN THE PROCESS OF FACILITATING THE RETURN OF THE PRODUCT FOR INSPECTION AND WILL UPDATE THIS REPORT SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19016028 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.