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

Model Number 27003

Device Problem Protective Measures Problem (3015)

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

Event Date 12/01/2023

Event Type  malfunction  

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.

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).

• Brand Name: ASTRAL 150 - AMER
• Type of Device: VENTILATOR, CONTINUOUS (FACILITY/HOME)
• Manufacturer (Section D): RESMED PTY LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• Manufacturer (Section G): RESMED PTY LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• Manufacturer Contact: jaklin aziz ; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 18414741
• MDR Text Key: 331638916
• Report Number: 3004604967-2023-00705
• 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: 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• 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
• Distributor Facility Aware Date: 12/01/2023
• Date Manufacturer Received: 12/01/2023
• Date Device Manufactured: 04/14/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1