DreamStation DreamStation BiPAP AVAPS30 AAM w/Humidifier, CARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00606959425514), received between Jan 27, 2026 and Jan 27, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Thermal Decomposition of Device” (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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2026Thermal Decomposition of Device

  THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE POWER SUPPLY HAS MELTED AND HAS A BURNING SMELL OCCURRED ON A DREAMSTATION BIPAP AVAPS30 DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE OCCURRENCE. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24189710 ↗

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