MAUDE Adverse Event Report: RESMED LTD ASTRAL 100 - EUR1

Model Number 27011

Device Problems Device Displays Incorrect Message (2591); Temperature Problem (3022)

Patient Problem Insufficient Information (4580)

Event Date 01/29/2023

Event Type  malfunction  

Manufacturer Narrative

The astral device was returned to a resmed authorized third party service center.Evaluation confirmed the reported complaint.The thermistor 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

It was reported to resmed that an astral device displayed an error message (sf116) related to ambient temperature measurement.There was no patient harm or serious injury reported as a result of this incident.

• Brand Name: ASTRAL 100 - EUR1
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 16448209
• MDR Text Key: 310331326
• Report Number: 3007573469-2023-00131
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00619498270118
• UDI-Public: (01)00619498270118(11)170406(10)1233461
• Combination Product (y/n): N
• Reporter Country Code: PL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: 505
• Type of Report: Initial
• Report Date: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 27011
• Device Catalogue Number: 27011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2023
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/27/2023
• Distributor Facility Aware Date: 01/29/2023
• Device Age: 69 MO
• Date Report to Manufacturer: 02/27/2023
• Date Manufacturer Received: 01/29/2023
• Date Device Manufactured: 04/06/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1