MAUDE Adverse Event Report: RESMED PTY LTD ASTRAL 150 DBL KIT - EUR4; VENTILATOR, CONTINUOUS (FACILITY/HOME)

Model Number 27064

Device Problem Unexpected Shutdown (4019)

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

Event Date 09/04/2023

Event Type  malfunction  

Manufacturer Narrative

The astral device was returned to resmed and an evaluation was performed.The reported complaint could not be confirmed during evaluation.The device operated per specifications.The device was serviced, cleaned and tested before it was returned to the customer.Resmed reference#: (b)(4).

Event Description

It was reported to resmed that an astral device powered down during ventilation.There was no patient harm or serious injury reported as a result of this incident.

Event Description

It was reported to resmed that an astral device powered down during ventilation.There was no patient harm or serious injury reported as a result of this incident.

Manufacturer Narrative

During evaluation of the device, signs of physical damage and water damage were seen both internally and externally of the device.Based on all available evidence and complaint investigations of a similar nature, an investigation determined that the reported complaint was due to contamination.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference (b)(4).

• Brand Name: ASTRAL 150 DBL KIT - EUR4
• 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: 18223325
• MDR Text Key: 329196644
• Report Number: 3007573469-2023-00648
• Device Sequence Number: 1
• Product Code: NOU
• UDI-Device Identifier: 00619498270644
• UDI-Public: (01)00619498270644(10)1391879
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

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: 27064
• Device Catalogue Number: 27064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2023
• 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: 02/08/2024
• Device Age: 51 MO
• Date Report to Manufacturer: 03/07/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/28/2023
• Supplement Dates Manufacturer Received: 02/08/2024
• Supplement Dates FDA Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1