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

Model Number 27093

Device Problems Failure to Power Up (1476); Unexpected Therapeutic Results (1631)

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

Event Date 11/08/2022

Event Type  malfunction  

Manufacturer Narrative

The astral device was returned to a resmed authorized third party service center.Evaluation could not confirm the reported complaint.The investigation methods, results, and conclusions are not finalized at this stage.If further information becomes available, a supplementary report will be submitted.Resmed reference#: (b)(4).

Event Description

It was reported to resmed that an astral device became inoperable.The device was not in patient use when the reported event occurred.

Manufacturer Narrative

The astral device was returned to resmed for an investigation.Review of the device data logs revealed the device was not able to startup.Performance testing could not reproduce the issue.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the device unable to startup was due to a software issue.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 became inoperable.The device was not in patient use when the reported event occurred.

• Brand Name: ASTRAL 150 - FUKUDA
• Type of Device: VENTILATOR, CONTINUOUS (FACILITY/HOME)
• 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: 16088550
• MDR Text Key: 308545803
• Report Number: 3004604967-2023-00004
• Device Sequence Number: 1
• Product Code: NOU
• UDI-Device Identifier: 00619498270934
• UDI-Public: (01)00619498270934(10)1516089
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 27093
• Device Catalogue Number: 27093
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/31/2023
• Date Manufacturer Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1