MAUDE Adverse Event Report: RESMED PTY LTD AIRCURVE 10 ST-A IVAPS AE 4G CO; VENTILATOR, CONTINUOUS, NON-LIFE SUPPORTING

Model Number	28224
Medical Device Problem Code	Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Codes	Loss of consciousness (2418); Respiratory Failure (2484)
Date of Event	12/12/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device is not available to be returned to resmed, therefore resmed is unable to confirm the alleged malfunction at this time.Resmed has requested additional information from the supplier regarding the reported incident.No further information has been made available to date.When more information becomes available, a final report will be submitted.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference: pr (b)(4).
Event or Problem Description
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 failed device.

• Brand Name: AIRCURVE 10 ST-A IVAPS AE 4G CO
• Common Device Name: VENTILATOR, CONTINUOUS, NON-LIFE SUPPORTING
• Manufacturer (Section D): RESMED PTY LTD; 1 elizabeth macarthur drive; bella vista; sydney, 2153 ; AS 2153
• MDR Report Key: 23013726
• Report Number: 3007573469-2025-00263
• Device Sequence Number: 9747088
• Product Code: NOU
• UDI-Device Identifier: 00619498282241
• UDI-Public: (01)00619498282241(10)1580090
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2025
• Report Date (Section F): 09/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 28224
• Device Catalogue Number: 28224
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/15/2025
• Device Age: 44 MO
• Date Report to Manufacturer: 09/02/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/10/2025
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown
• Date Report Sent to FDA: 09/02/2025