MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 - EUR2

Model Number 27023

Device Problems Electrical /Electronic Property Problem (1198); Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2020

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.(b)(4).Pending evaluation.

Event Description

It was reported to resmed that an astral device had main circuit board with thermal damage.There was no patient harm or a serious injury reported as a result of this incident.

Event Description

It was reported to resmed that an astral device had main circuit board with thermal damage.There was no patient harm or a serious injury reported as a result of this incident.

Manufacturer Narrative

The astral device was returned to resmed for an investigation.Performance testing and visual inspection could not confirm the reported complaint.The investigation determined that the main circuit board had a leaky super capacitor.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference#: (b)(4).

• Brand Name: ASTRAL 150 - EUR2
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 11032437
• MDR Text Key: 222658630
• Report Number: 3004604967-2020-01202
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K152068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 27023
• Device Catalogue Number: 27023
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 02/15/2021
• Date Manufacturer Received: 02/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1