AIRCURVE 28224Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00619498282241), received between Sep 10, 2025 and Sep 10, 2025 — classified as 2 deaths.

The most frequently reported specific device problem is “Therapeutic or Diagnostic Output Failure” (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 16, 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.

• DeathSep 10, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED TO RESMED THAT A PATIENT WITH A HISTORY OF HYPOVENTILATION SYNDROME AND OBSTRUCTIVE SLEEP APNEA (OSA) WITH MORBID OBESITY, USING AN AIRCURVE 10 ST-A DEVICE EXPIRED ON (B)(6) 2024 ALLEGEDLY DUE TO A DEVICE MALFUNCTION. IT WAS REPORTED THAT ON THE DAY OF INCIDENT; MULTIPLE POWER OUTAGES OCCURRED AT THE PATIENT'S RESIDENCE. IT WAS ALLEGED THAT DURING THESE POWER OUTAGES, THE DEVICE [?]CYCLED' MULTIPLE TIMES AND MAY HAVE MALFUNCTIONED. SHORTLY THEREAFTER, THE PATIENT DEVELOPED SIGNIFICANT SHORTNESS OF BREATH AND BECAME UNRESPONSIVE. THE PATIENT'S WIFE WAS UNABLE TO IMMEDIATELY CALL EMERGENCY SERVICES DUE TO THE OUTAGE. AFTER APPROXIMATELY 20 MINUTES, POWER WAS RESTORED AND EMERGENCY MEDICAL SERVICES WERE CONTACTED. THE PATIENT PASSED AWAY AT THE HOSPITAL ABOUT 4 HOURS LATER. IT WAS REPORTED THAT THE PATIENT HAD BECOME INCREASINGLY DEPENDENT ON THE DEVICE OVER THE YEARS. THE PATIENT'S WIFE REPORTED THAT THEY WERE NOT MADE AWARE THAT THEY WOULD NEED A BACKUP BATTERY OR 'UNINTERRUPTED POWER SUPPLY' FOR THE DEVICE. IT WAS REPORTED BY THE CORONER'S OFFICE THAT THE PATIENT'S PRIMARY CAUSE OF DEATH WAS HYPOVENTILATION SYNDROME AND OSA WITH RESPIRATORY FAILURE SECONDARY TO A FA

  Patient problems: Loss of consciousness; Respiratory Failure

  MAUDE report 23013726 ↗
• DeathSep 10, 2025Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED TO RESMED THAT A PATIENT WITH A HISTORY OF HYPOVENTILATION SYNDROME AND OBSTRUCTIVE SLEEP APNEA (OSA) WITH MORBID OBESITY, USING AN AIRCURVE 10 ST-A DEVICE EXPIRED ON (B)(6) 2024 ALLEGEDLY DUE TO A DEVICE MALFUNCTION. IT WAS REPORTED THAT ON THE DAY OF INCIDENT; MULTIPLE POWER OUTAGES OCCURRED AT THE PATIENT'S RESIDENCE. IT WAS ALLEGED THAT DURING THESE POWER OUTAGES, THE DEVICE CYCLED' MULTIPLE TIMES AND MAY HAVE MALFUNCTIONED. SHORTLY THEREAFTER, THE PATIENT DEVELOPED SIGNIFICANT SHORTNESS OF BREATH AND BECAME UNRESPONSIVE. THE PATIENT'S WIFE WAS UNABLE TO IMMEDIATELY CALL EMERGENCY SERVICES DUE TO THE OUTAGE. AFTER APPROXIMATELY 20 MINUTES, POWER WAS RESTORED AND EMERGENCY MEDICAL SERVICES WERE CONTACTED. THE PATIENT PASSED AWAY AT THE HOSPITAL ABOUT 4 HOURS LATER. IT WAS REPORTED THAT THE PATIENT HAD BECOME INCREASINGLY DEPENDENT ON THE DEVICE OVER THE YEARS. THE PATIENT'S WIFE REPORTED THAT THEY WERE NOT MADE AWARE THAT THEY WOULD NEED A BACKUP BATTERY OR 'UNINTERRUPTED POWER SUPPLY' FOR THE DEVICE. IT WAS REPORTED BY THE CORONER'S OFFICE THAT THE PATIENT'S PRIMARY CAUSE OF DEATH WAS HYPOVENTILATION SYNDROME AND OSA WITH RESPIRATORY FAILURE SECONDARY TO A FAILE

  Patient problems: Loss of consciousness; Respiratory Failure

  MAUDE report 23013722 ↗