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

Model Number	27919
Medical Device Problem Codes	Failure to Charge (1085); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to resmed that an astral device failed to charge its external battery and displayed a battery error message when the external battery was connected to the device.There was no patient harm or serious injury reported as a result of this incident.
Additional Manufacturer Narrative
Resmed has requested for the device to be returned so that an engineering investigation could be performed.The device has not been returned, therefore resmed is unable to confirm the alleged malfunction at this time.If further information becomes available, a supplementary report will be submitted.Resmed reference#: (b)(4).
Event or Problem Description
It was reported to resmed that an astral device failed to charge its external battery and displayed a battery error message when the external battery was connected to the device.There was no patient harm or serious injury reported as a result of this incident.
Additional Manufacturer Narrative
The astral device was not returned to resmed.An investigation was performed on all available information.Based on all available evidence, the investigation determined that the reported complaint was due to a faulty/defective external battery.Resmed¿s risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference#: (b)(4).

• 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
• MDR Report Key: 15889902
• Report Number: 3007573469-2022-00793
• Device Sequence Number: 20148140
• Product Code: NOU
• UDI-Device Identifier: 00619498279197
• UDI-Public: (01)00619498279197(11)201020(10)1491670
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2023
• Report Date (Section F): 04/06/2023
• 2 Devices were Involved in the Event: 1 2

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/09/2023
• Device Age: 24 MO
• Date Report to Manufacturer: 04/06/2023
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 11/30/2022
• Supplement Report FDA Received Date: 04/06/2023
• Date Device Manufactured: 11/01/2020
• 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: 04/06/2023