MAUDE Adverse Event Report: RESMED LTD MAIN PCB (ASTRAL 150) - 90HPA

Model Number 29052

Device Problem Capacitative Coupling (1079)

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

Event Date 11/08/2022

Event Type  malfunction  

Event Description

It was reported to resmed that an astral device displayed an error message (sf179) related to the super capacitor.There was no patient harm or serious injury reported as a result of this incident.

Manufacturer Narrative

The device was returned to an authorized resmed third party service center and an evaluation confirmed the complaint.Visual inspection of the main circuit board revealed a leaky super capacitor.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).

• Brand Name: MAIN PCB (ASTRAL 150) - 90HPA
• 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: 16064762
• MDR Text Key: 308370707
• Report Number: 3004604967-2022-00862
• Device Sequence Number: 1
• Product Code: NOU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172875
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: 505
• Type of Report: Initial
• Report Date: 12/28/2022

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?: No
• Distributor Facility Aware Date: 11/30/2022
• Initial Date Manufacturer Received: 11/30/2022
• Initial Date FDA Received: 12/28/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1