MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 DBL KIT FRA

Model Number 27074

Device Problem Power Problem (3010)

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

Event Date 02/24/2021

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 this issue.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the reported complaint was due to an isolated component failure within the device main circuit board.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference #: (b)(4).

Event Description

It was reported to resmed that an astral device had a power source detection issue.There was no patient harm or serious injury reported as a result of this incident.

• Brand Name: ASTRAL 150 DBL KIT FRA
• 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: 11566138
• MDR Text Key: 243555895
• Report Number: 3004604967-2021-00438
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K152068
• 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: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 27074
• Device Catalogue Number: 27074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2021
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/24/2021
• Date Manufacturer Received: 02/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1