DeVilbiss DV64DRecalls & reported problems
Devilbiss Healthcare LLC · IntelliPAP 2 autoadjust CPAP · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885304009245), received between Jan 19, 2024 and Jan 19, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Contamination” (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
- Contamination1
Patient problems
- Respiratory Tract Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 19, 2024Contamination; Contamination
DEVILBISS HEALTHCARE WAS NOTIFIED OF A COMPLAINT INVOLVING AN INTELLIPAP2 AUTO CPAP DEVICE, WHICH THE END-USER STATED, "MY INTELLIPAP2 HAS BEEN MALFUNCTIONING FOR SEVERAL WEEKS. YESTERDAY, IT EXPLODED BLACK STUFF ALL THROUGH THE MACHINE." THE END USER STATED SHE HAS "RESPIRATORY ISSUES, SINUS INFECTIONS AND CONGESTION." THE END-USER ALSO STATED THAT SHE "WAS PRESCRIBED ANTIBIOTICS AND A STEROID INHALER." THE END-USER INDICATED THAT SHE RECEIVED THE DEVICE IN 2016, AND THE SERIAL NUMBER CONFIRMS THE DEVICE IS 8 YEARS OLD, WHICH IS 3 YEARS BEYOND THE DEVICE'S EXPECTED SERVICE LIFE. THIS MODEL AUTO CPAP DOES NOT CONTAIN BLACK FOAM OR PE-PUR FOAM. DEVILBISS IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE DEVICE TO PERFORM A COMPREHENSIVE INVESTIGATION. AN UPDATE WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Patient problems: Respiratory Tract Infection
MAUDE report 18546452 ↗
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- DreamStation DreamStation Auto CPAP w/Humid w/Heated Tube, USRespironics, Inc. · VENTILATOR, NON-CONTINUOUS (RESPIRATOR)30 deaths3,981 reports
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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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