MAUDE Adverse Event Report: RESMED PTY LTD ASTRAL 100 - APAC2; VENTILATOR, CONTINUOUS (FACILITY/HOME)

Model Number 27082

Device Problem Protective Measures Problem (3015)

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

Event Date 04/03/2024

Event Type  malfunction  

Manufacturer Narrative

The device was returned to a third party service center and an evaluation confirmed the complaint.The main circuit board was replaced to address the issue.The device was serviced and fully 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

It was reported to resmed that an astral device displayed an error message (sf140) related to alarm priority.There was no patient harm or serious injury reported as a result of this incident.

• Brand Name: ASTRAL 100 - APAC2
• 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: 19218545
• MDR Text Key: 341707560
• Report Number: 3004604967-2024-00112
• Device Sequence Number: 1
• Product Code: NOU
• UDI-Device Identifier: 00619498270828
• UDI-Public: (01)00619498270828(10)1492067
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K172875
• 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: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 27082
• Device Catalogue Number: 27082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2024
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/03/2024
• Date Manufacturer Received: 04/03/2024
• Date Device Manufactured: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1