MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 -EUR4

Model Number 27063

Device Problem Inadequate User Interface (2958)

Patient Problem Dyspnea (1816)

Event Date 12/22/2020

Event Type  malfunction  

Manufacturer Narrative

Resmed has requested for the device to be returned so that an engineering investigation could be performed.The device has not been returned, therefore, resmed is unable to confirm the alleged malfunction at this time.Resmed reference#: (b)(4).

Event Description

It was reported to resmed that an astral device had a pixelated touchscreen while the patient complained of difficulty breathing.There was no serious injury reported as a result of this incident.

Manufacturer Narrative

The astral device was returned to resmed for an investigation.Review of the device data logs did not reveal evidence of a device malfunction.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the reported touchscreen issue was due to an isolated component failure within the device main circuit board (pcba).Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference#: (b)(4).

Event Description

It was reported to resmed that an astral device had a pixilated touchscreen while the patient complained of difficulty breathing.There was no serious injury reported as a result of this incident.

• Brand Name: ASTRAL 150 -EUR4
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 11216149
• MDR Text Key: 228253644
• Report Number: 3007573469-2021-00145
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 03/26/2021

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: 27063
• Device Catalogue Number: 27063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/26/2021
• Distributor Facility Aware Date: 03/17/2021
• Device Age: 41 MO
• Date Report to Manufacturer: 03/26/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/22/2021
• Supplement Dates Manufacturer Received: 03/17/2021
• Supplement Dates FDA Received: 03/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1