MAUDE Adverse Event Report: RESMED LTD ASTRAL 100 - APAC2; VENTILATOR, CONTINUOUS (FACILITY/HOME)

Model Number 27082

Device Problem Failure to Calibrate (2440)

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

Event Date 04/24/2023

Event Type  malfunction  

Event Description

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

Manufacturer Narrative

The astral device was returned to a third party service center.Evaluation confirmed the reported complaint.The pneumatic block was replaced to address the issue.The device was serviced and fully tested before it was returned to the customer.Resmed reference#: (b)(4).

• Brand Name: ASTRAL 100 - APAC2
• 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: 16990002
• MDR Text Key: 315842343
• Report Number: 3007573469-2023-00365
• Device Sequence Number: 1
• Product Code: NOU
• UDI-Device Identifier: 00619498270828
• UDI-Public: (01)00619498270828(10)1534083
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: 505
• Type of Report: Initial
• Report Date: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 27082
• Device Catalogue Number: 27082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2023
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/23/2023
• Distributor Facility Aware Date: 04/24/2023
• Device Age: 23 MO
• Date Report to Manufacturer: 05/23/2023
• Date Manufacturer Received: 04/24/2023
• Date Device Manufactured: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1