MAUDE Adverse Event Report: ResMed Pty Ltd Astral 100 - AMER; Continuous, Ventilator, Home Use

Model Number	27001
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	Loss of consciousness (2418)
Date of Event	05/25/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported to resmed that a patient expired while using an astral 100 device.It was reported that the patient became unresponsive while receiving ventilatory support from the device and no alarms were reportedly heard by the caregivers at the time of the event.The mother called for assistance, and family members initiated cpr prior to the arrival of emergency responders.Upon arrival of emergency responders, they assumed resuscitation efforts, and transported the patient by ambulance to a hospital, after which the patient was transferred to another hospital for a higher level of care.The patient was pronounced deceased at the hospital.
Additional Manufacturer Narrative
Resmed has requested for the device to be returned so that an engineering investigation can be performed.The device has not been returned, therefore, resmed is unable to confirm the alleged malfunction at this time.Resmed reference#: case-202608-7998.

• Brand Name: Astral 100 - AMER
• Common Device Name: Continuous, Ventilator, Home Use
• Manufacturer (Section D): ResMed Pty Ltd; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 50505593
• Report Number: 3007573469-2026-01337
• Device Sequence Number: 10211632
• Product Code: NOU
• UDI-Device Identifier: 00619498270019
• UDI-Public: (01)00619498270019(11)231122(10)1743853
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/28/2026
• Report Date (Section F): 08/28/2026

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: Other
• Device Model Number: 27001
• Device Catalogue Number: 27001
• Device Lot Number: 1743853
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/03/2026
• Device Age: 32 MO
• Event Location: Home
• Date Report to Manufacturer: 08/28/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/29/2023
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 24 MO
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/28/2026