MAUDE Adverse Event Report: RESMED LTD ASTRAL EXTERNAL BATTERY, AMERICAS; VENTILATOR, CONTINUOUS (FACILITY/HOME)

Model Number	27919
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2023
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 external battery was replaced to address the issue.The device was serviced and fully tested before it was returned to the customer.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference#: (b)(4).
Event or Problem Description
It was reported to resmed that an astral device external battery had depleted quickly.There was no patient harm or serious injury reported as a result of this incident.

• Brand Name: ASTRAL EXTERNAL BATTERY, AMERICAS
• Common Device Name: VENTILATOR, CONTINUOUS (FACILITY/HOME)
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• Manufacturer (Section G): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• Manufacturer Contact: michelle hughes ; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 17364467
• Report Number: 3004604967-2023-00439
• Device Sequence Number: 5289917
• Product Code: NOU
• UDI-Device Identifier: 00619498279197
• UDI-Public: (01)00619498279197(11)210908(10)1558186
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• 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: 505
• Type of Report: Initial
• Report Date (Section B): 07/20/2023

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: 27919
• Device Catalogue Number: 27919
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/23/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2023
• Initial Report FDA Received Date: 07/20/2023
• Date Device Manufactured: 09/14/2021
• 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