DreamStation DreamStation AVAPS 30 AAM, no Bluetooth, INTLRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00606959425071), received between Mar 24, 2025 and Jun 13, 2025 — classified as 2 deaths.

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathJun 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION FROM A CLINIC STATING THAT A PATIENT HAS PASSED AWAY. THERE IS NO ALLEGATION THAT THE DREAMSTATION BIPAP AVAPS DEVICE CONTRIBUTED TO THE DEATH. IT IS UNKNOWN IF THE PATIENT WAS ON/USING THE DEVICE DURING THE TIME OF DEATH. THE CLINICAL ASSESSMENT TEAM STATES THAT THE REPORTED EVENT MAKES NO ALLEGATION OF ANY SPECIFIC DEVICE MALFUNCTION, USER ERROR, FAILURE, LABELING, OR OTHER DEFICIENCY THAT IS RELEVANT TO THE HARMS REPORTED. BASED ON AVAILABLE INFORMATION AT THIS TIME, THE ALLEGED DEATH IS ASSESSED AS NOT RELATED TO THE DEVICE IN THIS CASE. THEREFORE, BASED ON INFORMATION AVAILABLE AT THIS TIME, THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH. NO FURTHER ACTION IS REQUIRED. IF ADDITIONAL INFORMATION IS OBTAINED ABOUT THIS EVENT, PLEASE SEND IT TO THE PMS CLINICAL EXPERT FOR REVIEW. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM ANY MALFUNCTION OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Insufficient Information

  MAUDE report 22207829 ↗
• DeathMar 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER RECEIVED INFORMATION STATING A PATIENT SADLY PASSED AWAY. THE PATIENT WAS USING A BIPAP AVAPS30 DEVICE, ALTHOUGH NO INFORMATION WAS PROVIDED TO VERIFY IF THE DEVICE WAS IN USE WHEN THE PATIENT PASSED. THE REPORTED EVENT MAKES NO ALLEGATION OF ANY SPECIFIC DEVICE MALFUNCTION, USE ERROR, FAILURE, LABELING, OR OTHER DEFICIENCY THAT IS RELEVANT TO THE REPORTED EVENT. ADDITIONALLY, THERE IS NO OTHER CLINICAL INFORMATION PROVIDED TO INDICATE ANY CAUSAL RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED DEATH. ALSO, PER REPORT OF THE EVENT, "THERE IS NO ALLEGATION THAT THE DEVICE CONTRIBUTED TO THE DEATH." THEREFORE, BASED ON AVAILABLE INFORMATION THE REPORTED DEATH IS ASSESSED AS NOT RELATED TO THE DEVICE IN THIS CASE AND DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. AT THIS TIME, WE ARE UNABLE TO CONFIRM IF ANY MALFUNCTION OCCURRED. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

  Patient problems: Insufficient Information

  MAUDE report 21678981 ↗

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, Classified
  DreamStation 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