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

Model Number	27001
Medical Device Problem Codes	Battery Problem (2885); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to resmed that an astral device displayed battery error messages.There was no harm or serious injury reported as a result of this incident.
Additional Manufacturer Narrative
The astral device was returned to resmed.The evaluation determined that there was no fault found with the returned device.The device was performing to specifications.The device was serviced and fully tested before it was returned to the customer.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
• 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: 24836177
• Report Number: 3004604967-2026-01152
• Device Sequence Number: 10305404
• 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
• 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): 04/09/2026

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: 03/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 04/09/2026
• 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