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

Model Number	27919
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to an authorized resmed third party service center and an evaluation confirmed the complaint.The battery was replaced to address this 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 device had an external battery with a reduced level of capacity.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: 15819666
• Report Number: 3004604967-2022-00769
• Device Sequence Number: 16922457
• Product Code: CBK
• 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): 11/17/2022

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?: No
• Distributor Facility Aware Date: 10/19/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 11/17/2022
• 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