MAUDE Adverse Event Report: RESMED LTD ASTRAL EXTERNAL BATTERY, AMERICAS

Model Number	27919
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to an authorized resmed third party service center for an evaluation and service.The customer was issued with a replacement external battery as part of a warranty claim.Resmed reference #: (b)(4).
Event or Problem Description
It was reported to resmed that an astral device failed to charge its internal battery.The device was not in patient use when the reported event occurred.
Additional Manufacturer Narrative
The device was received by resmed and an evaluation was performed.The reported failure could not be reproduced during evaluation and the device operated per specifications.The device was serviced, cleaned, calibrated and 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 failed to charge its external battery.The device was not in patient use when the reported event occurred.

• Brand Name: ASTRAL EXTERNAL BATTERY, AMERICAS
• 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: 13290798
• Report Number: 3004604967-2022-00048
• Device Sequence Number: 20133940
• Product Code: CBK
• UDI-Device Identifier: 00619498279197
• UDI-Public: (01)00619498279197(11)191030(10)1417058
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K152068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2022

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/07/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/21/2021
• Supplement Date Received by Manufacturer: 03/07/2022
• Initial Report FDA Received Date: 01/19/2022
• Supplement Report FDA Received Date: 03/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2019
• 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