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

Model Number	27003
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to resmed that an astral device displayed an error message (sf140) related to alarm priority.There was no harm or injury reported as a result of the incident.
Additional Manufacturer Narrative
The astral device was returned to resmed.Evaluation of the device and device logs have confirmed the reported complaint of sf140 alarm.Investigation has determined a fault with the supercapacitor lead to a secondary component failure on the main circuit board that resulted in a ventilation stop.Appropriate alarms (including sf140) sounded when the fault occurred which alerts the clinician/carer to intervene.No serious adverse event was associated with this incident.Replacing the main circuit board resolved the issue.Resmed is continuing to investigate this issue and whether any additional action is required.Resmed reference#: (b)(4).

• 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
• MDR Report Key: 25326564
• Report Number: 3007573469-2026-01199
• Device Sequence Number: 10142296
• Product Code: NOU
• UDI-Device Identifier: 00619498270033
• UDI-Public: (01)00619498270033(11)191219(10)1428276
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 05/28/2026
• Report Date (Section F): 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: 1428276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/01/2026
• Device Age: 75 MO
• Date Report to Manufacturer: 05/28/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2020
• 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: 05/28/2026