MAUDE Adverse Event Report: ResMed Pty Ltd Astral 100 - AMER; Continuous, Ventilator, Home Use

Model Number	27001
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	01/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to resmed that an astral device displayed a 'low pressure' alarm while in use.Learn circuit was performed and the device displayed 'without spo2 monitoring'.The patient was placed on a different device.The patient's spo2 was 88% and manual ventilation was provided.
Additional Manufacturer Narrative
The astral device was returned to a third-party service center.Error 121 displayed during learn circuit while using the patient's single limb circuit with leak.The astral device was returned to resmed for an engineering investigation.Visual inspection identified contamination within the device.Review of the device logs identified the device displayed multiple alm_109 circuit fault alarms during ventilation, however, device operation was continued.Performance testing could not reproduce learn circuit error 121 and alm_109 circuit fault due to evaporation or drying of the contamination and/or water ingress.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that learn circuit error 121 and alm_109 circuit fault were due to contamination and/or water ingress from operator misuse leading to incorrect reading of flow and proximal pressure values.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.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: 50332128
• Report Number: 3004604967-2026-01319
• Device Sequence Number: 5356777
• Product Code: NOU
• UDI-Device Identifier: 00619498270019
• UDI-Public: (01)00619498270019(11)230213(10)1687256
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 27001
• Device Catalogue Number: 27001
• Device Lot Number: 1687256
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/22/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2023
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 14 YR
• Patient Sex: Unknown