MAUDE Adverse Event Report: RESMED LTD ASTRAL 100 - AMER2

Model Number 27007

Device Problem Operating System Becomes Nonfunctional (2996)

Patient Problem Insufficient Information (4580)

Event Date 03/15/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned to an authorized resmed third party service center for an evaluation and service.The customer was issued with a replacement top case as part of a warranty claim.Resmed reference #: (b)(4).

Event Description

It was reported to resmed that an astral device had an unresponsive touchscreen.There was no patient harm or serious injury reported as a result of this incident.

• Brand Name: ASTRAL 100 - AMER2
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 11592860
• MDR Text Key: 243737638
• Report Number: 3007573469-2021-00469
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00619498270071
• UDI-Public: (01)00619498270071(11)190529(10)1374165
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 03/30/2021

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: 27007
• Device Catalogue Number: 27007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/30/2021
• Distributor Facility Aware Date: 03/15/2021
• Device Age: 21 MO
• Date Report to Manufacturer: 03/30/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/30/2021
• Date Device Manufactured: 06/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1