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

Model Number	27001
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The astral device was returned to resmed.Evaluation of the device confirmed the reported complaint of sf82 and identified sf140 related to alarm priority.The main circuit board was replaced to address the issue.The device was serviced and fully tested before it was returned to the customer.Resmed reference #: case (b)(4).
Event or Problem Description
It was reported to resmed that an astral device displayed an error message (sf82) related to the alarm system.There was no harm or serious injury reported as a result of this incident.

• 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: 24957849
• Report Number: 3007573469-2026-01163
• Device Sequence Number: 20185023
• Product Code: NOU
• UDI-Device Identifier: 00619498270019
• UDI-Public: (01)00619498270019(11)190801(10)1396742
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 04/22/2026
• Report Date (Section F): 04/22/2026

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: Lay User/Patient
• Device Model Number: 27001
• Device Catalogue Number: 27001
• Device Lot Number: 1396742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/23/2026
• Device Age: 78 MO
• Date Report to Manufacturer: 04/22/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2019
• 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: 04/22/2026