MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 - AMER; VENTILATOR, CONTINUOUS (FACILITY/HOME)

Model Number 27003

Device Problem Operating System Becomes Nonfunctional (2996)

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

Event Date 03/21/2022

Event Type  malfunction  

Manufacturer Narrative

The device was received by resmed and an evaluation confirmed the complaint.The main circuit board was replaced to address the issue.The device was serviced and fully tested before it was returned to the customer.Resmed reference #: (b)(4).

Event Description

It was reported to resmed that an astral device had an unresponsive touchscreen and displayed an error message (sf).The device was not in patient use when the reported event occurred.

Event Description

It was reported to resmed that an astral device had an unresponsive touchscreen and displayed an error message (sf).The device was not in patient use when the reported event occurred.

Manufacturer Narrative

The astral device was returned to resmed for an investigation.Performance testing confirmed the reported complaint.Based on all available evidence, the investigation determined that the reported complaint was due to soldering failure.Resmed¿s risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference #: (b)(4).

• Brand Name: ASTRAL 150 - AMER
• Type of Device: VENTILATOR, CONTINUOUS (FACILITY/HOME)
• 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: 14145313
• MDR Text Key: 295447305
• Report Number: 3004604967-2022-00263
• Device Sequence Number: 1
• Product Code: NOU
• UDI-Device Identifier: 00619498270033
• UDI-Public: (01)00619498270033(11)160225(10)1162379
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 2773046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 27003
• Device Catalogue Number: 27003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2022
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/30/2023
• Date Manufacturer Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1