MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 - APAC2

Model Number 27088

Device Problem Failure of Device to Self-Test (2937)

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 for an evaluation and service.The customer was issued with a replacement non-return valve assembly (nrv) as a part of a warranty claim.(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.

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.

Manufacturer Narrative

The astral device was not returned to resmed.An investigation was performed on all available information.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the reported complaint was due to a faulty/defective nrv.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference#: (b)(4).

• Brand Name: ASTRAL 150 - APAC2
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 11282497
• MDR Text Key: 230438850
• Report Number: 3007573469-2021-00238
• 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,Followup
• Report Date: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• 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: 06/01/2021
• Distributor Facility Aware Date: 05/10/2021
• Device Age: 24 MO
• Date Report to Manufacturer: 06/01/2021
• Date Manufacturer Received: 05/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1