MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 - AMER

Model Number 27003

Device Problem Operating System Becomes Nonfunctional (2996)

Patient Problem Insufficient Information (4580)

Event Date 03/04/2021

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 an unresponsive touchscreen.There was no patient harm or serious injury reported as a result of this incident.

Manufacturer Narrative

The astral device was not returned to resmed.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the reported complaint was due to a device specification limitation.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 an unresponsive touchscreen.There was no patient harm or serious injury reported as a result of this incident.

• Brand Name: ASTRAL 150 - AMER
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 11586434
• MDR Text Key: 243608837
• Report Number: 3007573469-2021-00446
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00619498270033
• UDI-Public: (01)00619498270033(11)180603(10)1306138
• 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: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 27003
• Device Catalogue Number: 27003
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/01/2021
• Distributor Facility Aware Date: 05/12/2021
• Device Age: 32 MO
• Date Report to Manufacturer: 06/01/2021
• Date Manufacturer Received: 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1