MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 - EUR1; VENTILATOR, CONTINUOUS (FACILITY/HOME)

Model Number 27013

Device Problem Failure to Calibrate (2440)

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

Event Date 03/03/2023

Event Type  malfunction  

Manufacturer Narrative

The pneumatic block was replaced to address the issue.The device was serviced and fully tested before it was returned to the customer.Based on all available evidence and complaint investigations of a similar nature, an investigation determined that the reported complaint was due to an isolated component failure within the device pneumatic block.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference#: (b)(4).

Event Description

During resmed evaluation, an astral device failed to complete its service test.There was no patient harm or serious injury reported as a result of this incident.

• Brand Name: ASTRAL 150 - EUR1
• Type of Device: VENTILATOR, CONTINUOUS (FACILITY/HOME)
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 16959501
• MDR Text Key: 315531481
• Report Number: 3007573469-2023-00363
• Device Sequence Number: 1
• Product Code: NOU
• UDI-Device Identifier: 00619498270132
• UDI-Public: (01)00619498270132(10)1448603
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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: 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 27013
• Device Catalogue Number: 27013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/18/2023
• Distributor Facility Aware Date: 04/19/2023
• Device Age: 35 MO
• Date Report to Manufacturer: 05/18/2023
• Date Manufacturer Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1