MAUDE Adverse Event Report: RESMED PTY LTD ASTRAL EXTERNAL BATTERY, AMERICAS; CONTINUOUS, VENTILATOR, HOME USE

Model Number	27919
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The astral device was returned to a third-party service center.Evaluation confirmed the reported complaint.The external battery requires replacement to address the issue.Resmed reference#: (b)(4),.
Event or Problem Description
It was reported to resmed that an astral device external battery displayed a battery error message.There was no patient involvement.

• Brand Name: ASTRAL EXTERNAL BATTERY, AMERICAS
• 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: 24058959
• Report Number: 3004604967-2026-01044
• Device Sequence Number: 21259478
• Product Code: NOU
• UDI-Device Identifier: 00619498279197
• UDI-Public: (01)00619498279197(11)241002(10)1828912
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: 505
• Type of Report: Initial
• Report Date (Section B): 01/13/2026

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: Other
• Device Model Number: 27919
• Device Catalogue Number: 27919
• Device Lot Number: 1828912
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/16/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown