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

Model Number 27918

Device Problems Premature Discharge of Battery (1057); Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned to resmed and an evaluation confirmed the complaint.The battery was replaced to address the issue.The device was serviced and fully tested before it was returned to the customer.Resmed reference#: (b)(4).

Event Description

It was reported to resmed that an astral device had an external battery with a reduced level of capacity.There was no patient harm or serious injury reported as a result of this incident.

Event Description

It was reported to resmed that an astral device had an external battery with a reduced level of capacity.There was no patient harm or serious injury reported as a result of this incident.

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).

• Brand Name: ASTRAL EXTERNAL BATTERY, ROW
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 10388835
• MDR Text Key: 202349663
• Report Number: 3007573469-2020-00818
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 27918
• Device Catalogue Number: 27918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/03/2021
• Distributor Facility Aware Date: 01/17/2021
• Device Age: 10 MO
• Date Report to Manufacturer: 02/03/2021
• Date Manufacturer Received: 01/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1