MAUDE Adverse Event Report: RESMED LTD ASTRAL 100 - EUR1

Model Number 27011

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2020

Event Type  malfunction  

Manufacturer Narrative

The device was returned to resmed 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.(b)(4).

Event Description

It was reported to resmed during evaluation that an astral device had a defective non-return valve (nrv) assembly.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 had failed to complete its internal self-test.There was no patient harm or serious injury reported as a result of this incident.

Manufacturer Narrative

Based on all available evidence and complaint investigations of a similar nature, an investigation determined that the reported complaint was due to a design specification limitation.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference #: (b)(4).

• Brand Name: ASTRAL 100 - EUR1
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 10933625
• MDR Text Key: 219523348
• Report Number: 3004604967-2020-01141
• 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: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 27011
• Device Catalogue Number: 27011
• Device Lot Number: 1199496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Distributor Facility Aware Date: 01/20/2021
• Date Manufacturer Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1