MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 - EUR2

Model Number 27023

Device Problems Inappropriate or Unexpected Reset (2959); Protective Measures Problem (3015)

Patient Problem Dyspnea (1816)

Event Type  Injury  

Manufacturer Narrative

The astral device was returned to resmed for an investigation.Review of the device data logs confirmed the occurrence of a safety reset and device restart within 20 seconds as per specifications.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the reported complaint was due to a software issue.Resmed's risk analysis for these failure modes concludes that the risk is acceptable.(b)(4).

Event Description

It was reported that an astral device underwent an unexpected safety reset while ventilating on a patient and the device reset took 10 minutes to restart.The patient was placed on a cough assist device due to breathing difficulties.

• Brand Name: ASTRAL 150 - EUR2
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 10951391
• MDR Text Key: 219862504
• Report Number: 3007573469-2020-01171
• 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
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 27023
• Device Catalogue Number: 27023
• Device Lot Number: 1332537
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/04/2020
• Distributor Facility Aware Date: 11/06/2020
• Device Age: 25 MO
• Event Location: Home
• Date Report to Manufacturer: 12/04/2020
• Date Manufacturer Received: 11/06/2020
• 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
• Patient Age: 65
• Patient Weight: 120