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

Model Number 27093

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 01/21/2024

Event Type  malfunction  

Event Description

It was reported to resmed that an astral device stopped ventilation.The device was replaced with a backup device.There was no patient harm or serious injury reported as a result of this incident.

Manufacturer Narrative

Resmed has requested for the device to be returned so that an engineering investigation can be performed.The device has not been returned, therefore resmed is unable to confirm the alleged malfunction at this time.If more information becomes available, a supplementary report will be submitted.Resmed reference#: (b)(4).

• Brand Name: ASTRAL 150 - FUKUDA
• Type of Device: VENTILATOR, CONTINUOUS (FACILITY/HOME)
• Manufacturer (Section D): RESMED PTY LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 18764714
• MDR Text Key: 336054808
• Report Number: 3007573469-2024-00041
• Device Sequence Number: 1
• Product Code: NOU
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27093
• Device Catalogue Number: 27093
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/22/2024
• Distributor Facility Aware Date: 01/25/2024
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/22/2024
• Date Manufacturer Received: 01/25/2024
• Date Device Manufactured: 11/29/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 13 YR
• Patient Sex: Female
• Patient Weight: 23 KG