DeVilbiss 5650IRecalls & reported problems
Devilbiss Healthcare LLC · PULMO-AIDE - International · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00885304000907), received between Jun 26, 2026 and Jun 26, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Sparking” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Sparking1
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.
MalfunctionJun 26, 2026Sparking
DRIVE MEDICAL WAS NOTIFIED OF AN INCIDENT INVOLVING A NEBULIZER COMPRESSOR BY THE PROVIDER WHO REPORTED THAT WHILE IN USE, SPARKS CAME OUT FROM THE DAMAGED PART OF THE POWER CORD. THE END USER WAS NOT INJURED AND DID NOT SEEK MEDICAL ATTENTION. AS PART OF ITS COMPLAINT REVIEW AND EVALUATION PROCESS, DRIVE MEDICAL WILL FILE AN UPDATE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25634801 ↗
Other Nebulizer (Direct Patient Interface) devices
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- Circulaire™ 0330Sunmed, LLC · Nebulizer (Direct Patient Interface)1 recall0 reports
- I neb 00Respironics Respiratory Drug Delivery (Uk) Ltd · NEBULIZER (DIRECT PATIENT INTERFACE)3 deaths15 reports
- VixOne 0209Westmed, Inc. · Nebulizer (Direct Patient Interface)13 reports
- HUDSON RCI IPN040620Teleflex Incorporated · NEBULIZER (DIRECT PATIENT INTERFACE)12 reports
- HUDSON RCI HUD05014Medline Industries, Inc. · Nebulizer (direct patient interface)6 reports
- HUDSON RCI IPN049808Teleflex Incorporated · NEBULIZER (DIRECT PATIENT INTERFACE)6 reports
- VixOne 0210Westmed, Inc. · Nebulizer (Direct Patient Interface)5 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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