MAUDE Adverse Event Report: RESMED PTY LTD MAIN PCB (ASTRAL 150) - 90HPA; VENTILATOR, CONTINUOUS (FACILITY/HOME)

Model Number 29052

Device Problem Failure to Power Up (1476)

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

Event Date 03/01/2024

Event Type  malfunction  

Manufacturer Narrative

The device was returned to resmed and an evaluation confirmed the complaint.The main circuit board was replaced to address the issue.The device was serviced and 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: MAIN PCB (ASTRAL 150) - 90HPA
• 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: 19000202
• MDR Text Key: 339004358
• Report Number: 3004604967-2024-00085
• Device Sequence Number: 1
• Product Code: NOU
• UDI-Device Identifier: 00619498290529
• UDI-Public: (01)00619498290529(10)1729709
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K172875
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/28/2024

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: 29052
• Device Catalogue Number: 29052
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/01/2024
• Initial Date Manufacturer Received: 03/01/2024
• Initial Date FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1