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

• 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
• Manufacturer (Section G): ResMed Pty Ltd; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• Manufacturer Contact: jaklin aziz ; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153 ; +61(426)226675
• MDR Report Key: 50505590
• Report Number: 3004604967-2026-01337
• Device Sequence Number: 10211274
• Product Code: NOU
• UDI-Device Identifier: 00619498270019
• UDI-Public: (01)00619498270019(11)231122(10)1743853
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K172875
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2026
• 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