MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 DBL KIT - EUR4

Model Number 27064

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

Patient Problem Insufficient Information (4580)

Event Date 08/11/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned to resmed for an engineering investigation.The investigation methods, results, and conclusion are not finalized at this stage.When more information is available a supplemental report will be submitted.Resmed reference #: (b)(4).

Event Description

It was reported to resmed that an astral device had a power source detection issue and an internal 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.Performance testing confirmed the reported complaint.The main circuit board was replaced to address the issue.The device was serviced and fully tested before it was returned to the customer.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the reported complaint was due to due to an isolated component failure within the device main circuit board.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 had a power source detection issue and an internal battery with a reduced level of capacity.There was no patient harm or serious injury reported as a result of this incident.

• Brand Name: ASTRAL 150 DBL KIT - EUR4
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 12448868
• MDR Text Key: 271934976
• Report Number: 3007573469-2021-00971
• 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: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 27064
• Device Catalogue Number: 27064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2021
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/14/2021
• Distributor Facility Aware Date: 09/16/2021
• Device Age: 74 MO
• Date Report to Manufacturer: 10/14/2021
• Date Manufacturer Received: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1