MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 - AMER; VENTILATOR, CONTINUOUS (FACILITY/HOME)

Model Number 27003

Device Problems Electrical /Electronic Property Problem (1198); Protective Measures Problem (3015)

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

Event Date 09/25/2023

Event Type  malfunction  

Manufacturer Narrative

Visual inspection of the main circuit board revealed a leaky super capacitor.The main circuit board was replaced to address the reported complaint.The device was serviced and tested before it was returned to the customer.Based on all available evidence and complaint investigations of a similar nature, an investigation determined that the reported complaint was due to super capacitor electrolyte leak.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference#: (b)(4).

Event Description

During evaluation by a third party service center, 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 - AMER
• Type of Device: VENTILATOR, CONTINUOUS (FACILITY/HOME)
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 18007643
• MDR Text Key: 326555492
• Report Number: 3007573469-2023-00611
• Device Sequence Number: 1
• Product Code: NOU
• UDI-Device Identifier: 00619498270033
• UDI-Public: (01)00619498270033(11)160426(10)1173917
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: 505
• Type of Report: Initial
• Report Date: 10/25/2023

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: 27003
• Device Catalogue Number: 27003
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/25/2023
• Distributor Facility Aware Date: 09/26/2023
• Device Age: 88 MO
• Date Report to Manufacturer: 10/25/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/25/2023
• Date Device Manufactured: 05/01/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1