MAUDE Adverse Event Report: RESMED PTY LTD ASTRAL 100 - AMER; CONTINUOUS, VENTILATOR, HOME USE

Model Number	27001
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to resmed that an astral device had a total power failure during testing.There was no patient involvement reported.
Additional Manufacturer Narrative
The astral device was not returned to resmed.The investigation methods, results, and conclusions are not finalised at this stage.When more information is available a supplementary report will be submitted.Resmed reference #: (b)(4).

• 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: 25351640
• Report Number: 3007573469-2026-01202
• Device Sequence Number: 10311077
• Product Code: NOU
• UDI-Device Identifier: 00619498270019
• UDI-Public: (01)00619498270019(11)210722(10)1546995
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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): 06/01/2026
• Report Date (Section F): 06/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 27001
• Device Catalogue Number: 27001
• Device Lot Number: 1546995
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/04/2026
• Device Age: 57 MO
• Date Report to Manufacturer: 06/01/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/26/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/01/2026