BiPAP AVAPS BiPAP AVAPS C Series, ITRecalls & reported problems
Respironics, Inc. · BiPAP AVAPS C Series, Italy · Class 2
All models of BiPAP AVAPS (13)
Data updated Oct 18, 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 00606959048171), received between Oct 10, 2023 and Oct 10, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Degraded” (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
- Degraded1
Patient problems
- Headache1
- Skin Inflammation/ Irritation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 10, 2023Degraded; Degraded
THE MANUFACTURER BECAME AWARE OF A USER OF A BIPAP AVAPS C SERIES DEVICE WAS EXPERIENCING HEADACHES AND SKIN IRRITATION, ESPECIALLY OF THE HEAD SINCE (B)(6) 2021. THERE WAS NO REPORT OF VISIBLE PARTICLES SEEN OF ANY KIND. THE DEVICE IS CURRENTLY AT THE PATIENT'S HOME. THE PRODUCT HAS NOT BEEN RETURNED FOR INVESTIGATION. THE MANUFACTURER'S INVESTIGATION IS ON-GOING. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
Patient problems: Headache; Skin Inflammation/ Irritation
MAUDE report 17908724 ↗
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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