MAUDE Adverse Event Report: RESMED LTD ASTRAL 100 - AMER; VENTILATOR, CONTINUOUS (FACILITY/HOME)

Model Number 27001

Device Problems Failure to Calibrate (2440); Failure of Device to Self-Test (2937)

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

Event Date 12/12/2022

Event Type  malfunction  

Manufacturer Narrative

The astral device was returned to resmed.Evaluation confirmed the reported complaint.The non-return valve (nrv) assembly was replaced to address the issue.The device was serviced and fully tested before it was returned to the customer.Resmed reference#: (b)(4).

Event Description

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

Manufacturer Narrative

Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the reported complaint was due to a faulty/defective nrv.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 internal self-test.There was no patient harm or serious injury reported as a result of this incident.

• Brand Name: ASTRAL 100 - AMER
• Type of Device: VENTILATOR, CONTINUOUS (FACILITY/HOME)
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• Manufacturer (Section G): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• Manufacturer Contact: michelle hughes ; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 16250206
• MDR Text Key: 309133927
• Report Number: 3004604967-2023-00065
• Device Sequence Number: 1
• Product Code: NOU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172875
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/04/2023

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: 27001
• Device Catalogue Number: 27001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2022
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/06/2023
• Initial Date Manufacturer Received: 12/29/2022
• Initial Date FDA Received: 01/26/2023
• Supplement Dates Manufacturer Received: 03/06/2023
• Supplement Dates FDA Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1