MAUDE Adverse Event Report: RESMED PTY LTD ASTRAL 150 - APAC2; VENTILATOR, CONTINUOUS (FACILITY/HOME)

Model Number 27088

Device Problem Failure to Power Up (1476)

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

Event Date 11/01/2023

Event Type  malfunction  

Manufacturer Narrative

The astral device was returned to a third party service center.Evaluation confirmed the reported 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 did not power on.There was no patient harm or serious injury reported as a result of this incident.

• Brand Name: ASTRAL 150 - APAC2
• Type of Device: VENTILATOR, CONTINUOUS (FACILITY/HOME)
• Manufacturer (Section D): RESMED PTY LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• Manufacturer (Section G): RESMED PTY LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• Manufacturer Contact: jaklin aziz ; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 18414191
• MDR Text Key: 331603201
• Report Number: 3004604967-2023-00698
• Device Sequence Number: 1
• Product Code: NOU
• UDI-Device Identifier: 00619498270880
• UDI-Public: (01)00619498270880(11)180805(10)1322335
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2023
• Distributor Facility Aware Date: 11/30/2023
• Date Manufacturer Received: 11/30/2023
• Date Device Manufactured: 08/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1