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

Model Number 29052

Device Problems Defective Component (2292); Device Displays Incorrect Message (2591)

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

Event Date 07/12/2022

Event Type  malfunction  

Manufacturer Narrative

The main circuit board was replaced to address the issue.The device was serviced and tested before returned to the customer.Resmed reference#: (b)(4).

Event Description

During evaluation by a resmed authorized third party service center, an astral device had a leaky super capacitor and 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.

• 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: 15511089
• MDR Text Key: 302344678
• Report Number: 3004604967-2022-00629
• Device Sequence Number: 1
• Product Code: CBK
• 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: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• 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: 09/09/2022
• Date Manufacturer Received: 09/09/2022
• Date Device Manufactured: 01/18/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1