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

Model Number 27083

Device Problem Unexpected Shutdown (4019)

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

Event Date 01/21/2024

Event Type  Injury  

Event Description

It was reported to resmed that an astral 150 device unexpectedly turned off during ventilation without prior alarm during patient use.The device was connected to an external battery and main power supply during the reported event.The patient was removed from the device, manually ventilated and placed on an alternate device.

Manufacturer Narrative

The device was returned to resmed and an evaluation was performed.The reported complaint could not be confirmed or reproduced during evaluation.The device will be serviced, cleaned, calibrated and tested before returning to the customer.Resmed reference#: (b)(4).

• Brand Name: ASTRAL 150 - APAC
• 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: 18862944
• MDR Text Key: 337179289
• Report Number: 3007573469-2024-00060
• Device Sequence Number: 1
• Product Code: NOU
• UDI-Device Identifier: 00619498270835
• UDI-Public: (01)00619498270835(10)1348401
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 27083
• Device Catalogue Number: 27083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/07/2024
• Distributor Facility Aware Date: 02/09/2024
• Device Age: 61 MO
• Event Location: Home
• Date Report to Manufacturer: 03/07/2024
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Sex: Female
• Patient Weight: 48 KG