BiPAP autoSV Advanced System One 60 SeriesRecalls & reported problems across all models
Respironics, Inc. · 19 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,166
- Deaths reported
- 29
- Injuries reported
- 219
- Recalls
- 0
We found 19 models of BiPAP autoSV Advanced System One 60 Series by Respironics, Inc. in the FDA's device registry (GUDID). Together they are named in 1,166 adverse event reports in the FDA's MAUDE database, received between May 25, 2021 and Jul 27, 2026 — classified as 29 deaths, 219 injuries, 918 malfunctions.
The most frequently reported specific device problem is “Degraded” (1,151 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported BiPAP autoSV Advanced System One 60 Series problems
Device problems
- Degraded1,151
- Contamination135
- Overheating of Device24
- Adverse Event Without Identified Device or Use Problem17
- Thermal Decomposition of Device4
- Contamination /Decontamination Problem3
- Material Integrity Problem3
- Ambient Noise Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions776
- Unspecified Respiratory Problem136
- Cancer100
- Headache95
- Dizziness72
- Dyspnea61
- Unspecified Kidney or Urinary Problem57
- Asthma47
BiPAP autoSV Advanced System One 60 Series models
19 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BiPAP autoSV Advanced System One 60 Series BiPAP autoSV Advanced with Humidifier, 60 Series, USVENTILATOR, NON-CONTINUOUS (RESPIRATOR)9 deaths494 reports
- BiPAP autoSV Advanced System One 60 Series BiPAP autoSV Advanced w/H Tube Humid, 60 Series, USVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING3 deaths209 reports
- BiPAP autoSV Advanced System One 60 Series BiPAP autoSV Advanced, 60 Series, USVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING7 deaths123 reports
- BiPAP autoSV Advanced System One 60 Series BiPAP autoSV Advanced w/Humidifier, 30cm, 60 Series, USVENTILATOR, NON-CONTINUOUS (RESPIRATOR)4 deaths86 reports
- BiPAP autoSV Advanced System One 60 Series BiPAP autoSV Advanced w/H Tube Humid, 60 Series, USVENTILATOR, NON-CONTINUOUS (RESPIRATOR)63 reports
- BiPAP autoSV Advanced System One 60 Series BiPAP autoSV Advanced, 30cm, 60 Series, USVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING1 death55 reports
- BiPAP autoSV Advanced System One 60 Series BiPAP autoSV Advanced System One, 60 Series, USVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING3 deaths33 reports
- BiPAP autoSV Advanced System One 60 Series BiPAP autoSV Advanced, 60 Series, FRVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING32 reports
- BiPAP autoSV Advanced System One 60 Series BiPAP autoSV Advanced w/H Tube Humid, 60 Series, CAVENTILATOR, NON-CONTINUOUS (RESPIRATOR)22 reports
- BiPAP autoSV Advanced System One 60 Series BiPAP autoSV Advanced, 60 Series, DEVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING1 death15 reports
- BIPAP autoSV Advanced System One 60 Series BiPAP autoSV Advanced, 60 Series, 30 cm, USVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING1 death12 reports
- BiPAP autoSV Advanced System One 60 Series BiPAP autoSV Advanced, 60 Series, INTLVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING8 reports
- BiPAP autoSV Advanced System One 60 Series BiPAP autoSV Advanced with Humidifier, 60 Series, CAVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING4 reports
- BiPAP autoSV Advanced System One 60 Series BiPAP autoSV Advanced System One, 60 Series, INTLVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING3 reports
- BiPAP autoSV Advanced System One 60 Series BiPAP autoSV Advanced System One 60 Series, AUVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING2 reports
- BiPAP autoSV Advanced System One 60 Series BiPAP autoSV Advanced w/H Tube Hum, 30cm, 60 Series, CAVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING2 reports
- BiPAP autoSV Advanced System One 60 Series BiPAP autoSV Advanced w/Humid, System One 60 Srs, AUVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING1 report
- BiPAP autoSV Advanced System One 60 Series BiPAP autoSV Advanced w/H Tube Humid, Sys One 60 SeriesVENTILATOR, NON-CONTINUOUS (RESPIRATOR)1 report
- BiPAP autoSV Advanced System One 60 Series BiPAP autoSV Advanced, w/HT Humid, St Tube, 60 Series, CAVENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING1 report
Recent BiPAP autoSV Advanced System One 60 Series adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJul 27, 2026Thermal Decomposition of Device
A BiPAP autoSV ADV device was returned to the service center for evaluation. There was no initial alleged complaint found.During the evaluation conducted at the third-party service center, the device was visually inspected, and no evidence of foam particles was observed.Additionally, the service technician identified a burnt connector, and the device was forwarded to RIQL for further investigation.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50012255 ↗MalfunctionJul 27, 2026Thermal Decomposition of Device
A BiPAP autoSV ADV device was returned to the service center for evaluation. There was no initial alleged complaint found.During the evaluation of the device at the third-party service center, the device was visually inspected and noticed the connecter was burned.Upon review of the reported event, the service center has been instructed to return the device to the Product investigation lab (PIL) for further investigation.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50009605 ↗MalfunctionJul 27, 2026Thermal Decomposition of Device
A BiPAP autoSV ADV device was returned to a service center with no initial alleged complaint. During the evaluation of the device at the third-party service center the device was visually inspected, and no evidence of foam degradation was found. Moreover, the device had burnt power connector. In addition, the device was scrapped by the service center after the evaluation was completed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50002011 ↗MalfunctionJul 3, 2026Degraded
A BIPAP AUTOSV ADV DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND VISIBLE FOAM DEGRADATION WERE OBSERVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25708066 ↗MalfunctionJul 3, 2026Degraded
A BIPAP AUTOSV ADV DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. DURING THE EVALUATION, THE DEVICE WAS VISUALLY INSPECTED AND FOAM WAS OBSERVED IN TECHNICAL FINDINGS. ADDITIONALLY, THE PATIENT'S COMPLAINT WAS CONFIRMED AND THE DEVICE WAS SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25703089 ↗MalfunctionJul 2, 2026Degraded
A BIPAP AUTOSV DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE AS PART OF THE SOUND ABATEMENT FOAM RECALL PROCESS. DURING THE EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN OBSERVED VISIBLE FOAM PARTICLES. ADDITIONALLY, UNRELATED TO THE REPORTABLE MALFUNCTION, THE TECHNICIAN OBSERVED DESTROYED POWER CONNECTOR AND THE EVALUATION OF THE DEVICE DATA IDENTIFIED UNRELATED ERROR CODES. THESE ERROR CODES ARE CONSISTENT WITH NORMAL DEVICE OPERATION AND EXPECTED USE CONDITIONS AND ARE NOT CONSIDERED REPORTABLE UNDER MEDICAL DEVICE REPORTING REQUIREMENTS. NO EVIDENCE WAS IDENTIFIED TO SUGGEST THAT THESE ERROR CODES CONTRIBUTED TO OR CAUSED THE REPORTED EVENT. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25698126 ↗MalfunctionJun 29, 2026Degraded
THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. A BIPAP AUTOSV ADV DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH NO INITIAL ALLEGED COMPLAINT. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER THE DEVICE WAS VISUALLY INSPECTED AND EVIDENCE OF FOAM DEGRADATION WAS FOUND. MOREOVER, THE DEVICE HAD NO CONTAMINATION AND UNRELATED ERROR CODES. IN ADDITION, THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25659210 ↗MalfunctionJun 24, 2026Thermal Decomposition of Device; Power Problem
THE MANUFACTURER BECAME AWARE OF AN EVENT INVOLVING A BIPAP AUTOSV ADV DEVICE THAT WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE AS PART OF THE SOUND ABATEMENT FOAM RECALL PROCESS. DURING EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN OBSERVED A BURNT HUMIDIFIER CONNECTOR. ADDITIONALLY, UNRELATED TO THE REPORTABLE MALFUNCTION, DUST CONTAMINATION AND A NO-POWER CONDITION WERE OBSERVED. NO VISIBLE FOAM PARTICLES WERE IDENTIFIED DURING THE INSPECTION. FOLLOWING COMPLETION OF THE EVALUATION, THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, PERMANENT IMPAIRMENT, OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. BASED ON THE IDENTIFICATION OF A BURNT HUMIDIFIER CONNECTOR DURING DEVICE EVALUATION, THIS EVENT WAS DETERMINED TO BE REPORTABLE UNDER FDA 21 CFR PART 803 AS A PRODUCT MALFUNCTION AND/OR POTENTIAL SERIOUS INJURY EVENT. THE DEVICE WAS FORWARDED FOR FURTHER INVESTIGATION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF SIGNIFICANT NEW INFORMATION BECOMES AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25611299 ↗MalfunctionJun 18, 2026Degraded
A BIPAP AUTOSV ADV DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. DURING THE EVALUATION OF THE DEVICE AT THE SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED, AND FOAM PARTICLES WERE OBSERVED INSIDE THE ASSEMBLY. ADDITIONALLY, THE DEVICE WAS SCRAPPED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25553536 ↗MalfunctionJun 17, 2026Degraded
THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. A BIPAP AUTOSV ADV DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH NO INITIAL ALLEGED COMPLAINT. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED, AND EVIDENCE OF FOAM DEGRADATION/PARTICLES WAS FOUND. ADDITIONALLY, THE EVALUATION OF THE DEVICE DATA IDENTIFIED UNRELATED ERROR CODES. THESE ERROR CODES ARE CONSISTENT WITH NORMAL DEVICE OPERATION AND EXPECTED USE CONDITIONS AND ARE NOT CONSIDERED REPORTABLE UNDER MEDICAL DEVICE REPORTING REQUIREMENTS. NO EVIDENCE WAS IDENTIFIED TO SUGGEST THAT THESE ERROR CODES CONTRIBUTED TO OR CAUSED THE REPORTED EVENT. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25538635 ↗MalfunctionJun 12, 2026Degraded
THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. A BIPAP AUTOSV ADV DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH NO INITIAL ALLEGED COMPLAINT. DURING THE EVALUATION OF THE DEVICE, THE THIRD-PARTY SERVICE CENTER VISUALLY INSPECTED THE DEVICE AND OBSERVED VISIBLE FOAM PARTICLES. ADDITIONALLY, THE SERVICE TECHNICIAN FOUND MOISTURE CONTAMINATION AND THE EVALUATION OF THE DEVICE DATA IDENTIFIED UNRELATED ERROR CODES. THESE ERROR CODES ARE CONSISTENT WITH NORMAL DEVICE OPERATION AND EXPECTED USE CONDITIONS AND ARE NOT CONSIDERED REPORTABLE UNDER MEDICAL DEVICE REPORTING REQUIREMENTS. NO EVIDENCE WAS IDENTIFIED TO SUGGEST THAT THESE ERROR CODES CONTRIBUTED TO OR CAUSED THE REPORTED EVENT. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25493647 ↗MalfunctionJun 12, 2026Degraded; Overheating of Device
A BIPAP AUTOSV DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE WITH AN INITIAL ALLEGATION OF A BURNT CONNECTOR. THERE WAS NO REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. DURING THE EVALUATION OF THE DEVICE, THE COMPLAINT WAS CONFIRMED. THE SERVICE TECHNICIAN ALSO OBSERVED VISIBLE FOAM PARTICLES. DUE TO THE ALLEGED MALFUNCTION, THE DEVICE WILL BE RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LAB FOR ADDITIONAL TESTING. THE ROOT CAUSE IS NOT CONFIRMED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25492555 ↗MalfunctionJun 11, 2026Degraded
A BIPAP AUTOSV ADV DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE AS PART OF THE SOUND ABATEMENT FOAM RECALL PROCESS. THERE WAS NO REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED, AND EVIDENCE OF VISIBLE FOAM PARTICLES WAS FOUND. ADDITIONALLY, THE SERVICE TECHNICIAN ALSO NOTED LOOSE POWER CONNECTOR AND DUST CONTAMINATION. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25479818 ↗MalfunctionJun 11, 2026Degraded
A BIPAP AUTOSV ADV WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE AS PART OF THE SOUND ABATEMENT FOAM RECALL PROCESS. DURING THE EVALUATION OF THE DEVICE, THE SERVICE TECHNICIAN OBSERVED VISIBLE FOAM. ADDITIONALLY, UNRELATED TO THE REPORTABLE MALFUNCTION, THE TECHNICIAN OBSERVED AN ERROR CODE. THE DEVICE WAS SCRAPPED AFTER THE EVALUATION WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25474483 ↗MalfunctionJun 10, 2026Degraded
THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. A BIPAP AUTOSV ADV DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH NO INITIAL ALLEGED COMPLAINT. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED, AND EVIDENCE OF VISIBLE FOAM PARTICLES WAS FOUND INSIDE THE ASSEMBLY. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25463131 ↗
Other Respironics, Inc. products
- REMstar System One 60 Series92 models · 37,934 reports
- Philips Trilogy Ventilator90 models · 36,113 reports · 22 recalls
- Philips DreamStation190 models · 32,422 reports
- Trilogy46 models · 21,644 reports · 11 recalls
- Trilogy Evo20 models · 5,473 reports · 12 recalls
- Trilogy 1008 models · 5,088 reports
- BiPAP System One 60 Series40 models · 4,599 reports
- BiPAP A4037 models · 1,606 reports · 3 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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