MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 - APAC1; VENTILATOR, CONTINUOUS (FACILITY/HOME)

Model Number	27083
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2023
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 psu was replaced to address the issue.The device was serviced and fully tested before it was returned to the customer.Resmed reference#: (b)(4).
Event or Problem Description
It was reported to resmed that an astral power supply unit (psu) was inoperable.There was no patient harm or serious injury reported as a result of this incident.

• Brand Name: ASTRAL 150 - APAC1
• Common Device Name: VENTILATOR, CONTINUOUS (FACILITY/HOME)
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 17056219
• Report Number: 3007573469-2023-00389
• Device Sequence Number: 6693433
• Product Code: NOU
• UDI-Device Identifier: 00619498279661
• UDI-Public: (01)00619498279661(10)1537417
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/02/2023
• Report Date (Section F): 06/02/2023

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: 27083
• Device Catalogue Number: 27083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/09/2023
• Device Age: 23 MO
• Date Report to Manufacturer: 06/02/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/02/2023