MAUDE Adverse Event Report: RESMED PTY LTD ASTRAL 150 - AMER; CONTINUOUS, VENTILATOR, HOME USE

Model Number	27003
Medical Device Problem Code	Inadequate User Interface (2958)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The astral device was returned to resmed.Evaluation confirmed the reported complaint.Touchscreen was calibrated to address the issue.The device was serviced and fully tested before it was returned to the customer.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference#: (b)(4).
Event or Problem Description
It was reported to resmed that an astral device had an unresponsive touchscreen.There was no harm or serious injury reported as a result of this incident.

• Brand Name: ASTRAL 150 - 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
• MDR Report Key: 25326667
• Report Number: 3004604967-2026-01201
• Device Sequence Number: 9805803
• Product Code: NOU
• UDI-Device Identifier: 00619498270033
• UDI-Public: (01)00619498270033(11)220216(10)1597164
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K172875
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/28/2026

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: 27003
• Device Catalogue Number: 27003
• Device Lot Number: 1597164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2026
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/29/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown