BiPAP autoSV Advanced System One 60 Series BiPAP autoSV Advanced System One 60 Series, AURecalls & reported problems
Respironics, Inc. · BiPAP autoSV Advanced System One 60 Series, Australia · Class 2
All models of BiPAP autoSV Advanced System One 60 Series (19)
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 00606959006201), received between Mar 14, 2022 and May 24, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Degraded” (2 reports).
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.
Most reported problems
Device problems
- Degraded2
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Skin Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 24, 2022Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM.THE PATIENT ALLEGED FACE INFECTION . THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
Patient problems: Skin Infection
MAUDE report 14488303 ↗MalfunctionMar 14, 2022Degraded; Degraded
THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BILEVEL POSITIVE AIRWAY PRESSURE (BIPAP) DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT ALLEGED VISUALIZATION OF BLACK PARTICLES. THERE WAS NO REPORT OF PATIENT HARM/INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13756701 ↗
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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