MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 - APAC2

Model Number 27088

Device Problem Failure to Calibrate (2440)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to an authorized resmed third party service center and an evaluation confirmed the complaint.The non-return valve (nrv) assembly was replaced to address this issue.The device was serviced and fully tested before it was returned to the customer.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 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 - APAC2
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 8895824
• MDR Text Key: 154434789
• Report Number: 3007573469-2019-00262
• Device Sequence Number: 1
• Product Code: NOU
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 08/15/2019

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: 27088
• Device Catalogue Number: 27088
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/15/2019
• Distributor Facility Aware Date: 07/19/2019
• Device Age: 24 MO
• Date Report to Manufacturer: 08/15/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1