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

Model Number	27919
Medical Device Problem Code	Failure to Charge (1085)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to resmed and an evaluation confirmed the complaint.The external battery pack was replaced to address this 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.(b)(4).
Event or Problem Description
It was reported to resmed that an astral external battery was failing to charge.There was no patient harm or serious injury reported as a result of this incident.

• Brand Name: ASTRAL EXTERNAL BATTERY, AMERICAS
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 8451205
• Report Number: 3004604967-2019-00105
• Device Sequence Number: 11484842
• Product Code: CBK
• UDI-Device Identifier: 00619498279197
• UDI-Public: (01)00619498279197(11)180822(10)1323837
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K152068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/26/2019

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: 03/07/2019
• Distributor Facility Aware Date: 02/28/2019
• Device Age: 5 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 03/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1