MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 - EUR2

Model Number 27023

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/27/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned to resmed and an evaluation confirmed the reported complaint.Visual inspection of the airpath and internal pneumatic block revealed black deposits.The device was deemed beyond repair and scrapped.Resmed reference#: (b)(4).

Event Description

It was reported to resmed that an astral device failed its service tests.There was no patient harm or serious injury reported as a result of this incident.

• Brand Name: ASTRAL 150 - EUR2
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• Manufacturer (Section G): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• Manufacturer Contact: michelle hughes ; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 16478965
• MDR Text Key: 310629064
• Report Number: 3004604967-2023-00143
• Device Sequence Number: 1
• Product Code: NOU
• UDI-Device Identifier: 00619498270231
• UDI-Public: (01)00619498270231(11)161127(10)1209113
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K172875
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: 505
• Type of Report: Initial
• Report Date: 03/03/2023

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: 27023
• Device Catalogue Number: 27023
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 02/03/2023
• Initial Date Manufacturer Received: 02/03/2023
• Initial Date FDA Received: 03/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1