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

Model Number 27003

Device Problems Protective Measures Problem (3015); Complete Loss of Power (4015)

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

Event Date 11/30/2023

Event Type  malfunction  

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 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 displayed an error message (sf) and ventilation stopped.There was no patient harm or serious injury reported as a result of this incident.

• 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
• MDR Report Key: 18414415
• MDR Text Key: 331581811
• Report Number: 3007573469-2023-00703
• Device Sequence Number: 1
• Product Code: NOU
• UDI-Device Identifier: 00619498270033
• UDI-Public: (01)00619498270033(11)210620(10)1543621
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/28/2023
• Distributor Facility Aware Date: 11/30/2023
• Device Age: 29 MO
• Date Report to Manufacturer: 12/28/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/28/2023
• Date Device Manufactured: 06/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1