MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 - DEU

Model Number 27053

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 02/09/2023

Event Type  malfunction  

Manufacturer Narrative

The astral device was returned to resmed.Evaluation confirmed the reported complaint.Visual inspection of the main circuit board revealed super capacitor leakage.The main circuit board will be replaced to address the reported complaint.Resmed reference#: (b)(4).

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.

• Brand Name: ASTRAL 150 - DEU
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 16517528
• MDR Text Key: 311038999
• Report Number: 3007573469-2023-00153
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00619498270538
• UDI-Public: (01)00619498270538(11)160601(10)1179369
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 27053
• Device Catalogue Number: 27053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/09/2023
• Distributor Facility Aware Date: 02/10/2023
• Device Age: 80 MO
• Date Report to Manufacturer: 03/09/2023
• Date Manufacturer Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1