MAUDE Adverse Event Report: RESMED LTD ASTRAL BATTERY PACK

Model Number 19620

Device Problem Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Date 10/14/2020

Event Type  malfunction  

Manufacturer Narrative

The astral device was returned to resmed for an investigation.Review of the device data logs confirmed the reported complaint.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the reported complaint was due to an isolated component failure within the device battery assembly.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference#: (b)(4).

Event Description

It was reported to resmed that an astral device displayed an internal battery degraded warning alarm.The device was not in patient use when the reported event occurred.

• Brand Name: ASTRAL BATTERY PACK
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AU 2153
• Manufacturer (Section G): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AU 2153
• Manufacturer Contact: michelle hughes ; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 11283414
• MDR Text Key: 232396516
• Report Number: 3004604967-2021-00239
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 19620
• Device Catalogue Number: 19620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/08/2021
• Date Manufacturer Received: 01/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1