DreamStation DreamStation BiPAP AVAPS 30 AE No Bluetooth. INTLRecalls & reported problems
Respironics, Inc. · DreamStation AVAPS 30 AE, no BlueTooth, International · Class 2
All models of Philips DreamStation (190)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00606959425101), received between Dec 26, 2024 and Jul 21, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (1 report).
1 other recall cover devices cleared under the same FDA submission (K102465); they may or may not involve this specific model.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Electrical /Electronic Property Problem1
- No Apparent Adverse Event1
- No Display/Image1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 21, 2025No Display/Image; No Display/Image
THE MANUFACTURER RECEIVED INFORMATION ALLEGING NO DISPLAY ¿ NO ALARM. THERE WAS NO HARM OR INJURY REPORTED. DISTRIBUTOR REPLACED THE UI PANEL TO ADDRESS THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22553884 ↗MalfunctionDec 26, 2024Electrical /Electronic Property Problem; No Apparent Adverse Event; Electrical /Electronic Property Problem; No Apparent Adverse Event
THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21019526 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K102465. One submission often covers many models, so check the product and lot details in each record.
- Z-1973-2021 · Jun 14, 2021 · Open, ClassifiedDreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+ Continuous Ventilator, Non-life Supporting The Philips Respironic
Other VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING devices
- DreamStation BiPAP ST30 00Respironics, Inc. · VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING5 deaths547 reports
- DreamStation BiPAP ST30 00Respironics, Inc. · VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING3 deaths283 reports
- BiPAP AVAPS BiPAP AVAPS C Series, 30cm, INTLRespironics, Inc. · VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING274 reports
- BiPAP autoSV Advanced System One 60 Series BiPAP autoSV Advanced w/H Tube Humid, 60 Series, USRespironics, Inc. · VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING3 deaths209 reports
- BiPAP S/T C-Series BiPAP S/T C Series Core Pack, 30cm, USRespironics, Inc. · VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING1 death200 reports
- DreamStation BiPAP AVAPS DreamStation BiPAP AVAPS30 w/Humidifier w/Cell, USRespironics, Inc. · VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING4 deaths174 reports
- DreamStation BiPAP AVAPS DreamStation AVAPS30 w/Humid w/H Tube w/Cell, USRespironics, Inc. · VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING2 deaths144 reports
- BiPAP A30 00Respironics, Inc. · VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING2 recalls29 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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