MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 - AMER

Model Number 27003

Device Problems Failure to Charge (1085); Failure to Shut Off (2939)

Patient Problem No Consequences Or Impact To Patient (2199)

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 failed to charge its internal battery and failed to power down.There was no patient harm or serious injury reported as a result of this incident.

Event Description

It was reported to resmed that an astral device failed to charge its internal battery and failed to power down.There was no patient harm or serious injury reported as a result of this incident.

Manufacturer Narrative

The device was not returned to resmed for an evaluation.A resmed customer representative assisted the customer with instructions to perform a hard reset of the device.The hard reset was able to resolve the issue.Based on all available evidence and complaint investigations of a similar nature, an investigation determined that the reported complaints were due to a software issue.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference #: (b)(4).

• Brand Name: ASTRAL 150 - AMER
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 8886527
• MDR Text Key: 154284889
• Report Number: 3007573469-2019-00255
• Device Sequence Number: 1
• Product Code: NOU
• UDI-Device Identifier: 00619498270033
• UDI-Public: (01)00619498270033(11)161213(10)1205499
• 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: 05/19/2020

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: 27003
• Device Catalogue Number: 27003
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/19/2020
• Distributor Facility Aware Date: 10/09/2019
• Device Age: 33 MO
• Date Report to Manufacturer: 05/19/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2019
• Supplement Dates Manufacturer Received: 10/09/2019
• Supplement Dates FDA Received: 05/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1