MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 DBL KIT FRA

Model Number 27074

Device Problem Failure to Calibrate (2440)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/23/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned to resmed and an evaluation confirmed the complaint.The non-return valve was replaced to address the issue.The device was serviced and fully tested before it was returned to the customer.Resmed's risk analysis for these failure modes concludes that the risk is acceptable.Resmed reference#: (b)(4).

Event Description

It was reported to resmed that an astral device failed to complete its internal self-test.There was no patient harm or serious injury reported as a result of this incident.

• Brand Name: ASTRAL 150 DBL KIT FRA
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 11276091
• MDR Text Key: 230227605
• Report Number: 3007573469-2021-00221
• Device Sequence Number: 1
• Product Code: NOU
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 27074
• Device Catalogue Number: 27074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/03/2021
• Distributor Facility Aware Date: 01/05/2021
• Device Age: 57
• Date Report to Manufacturer: 02/03/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/03/2021
• 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