MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 -EUR4

Model Number 27063

Device Problems Failure to Charge (1085); Failure to Calibrate (2440)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to resmed and an evaluation confirmed the complaint.The main circuit board, internal battery and pneumatic block was replaced to address this issue.The device was serviced and fully tested before it was returned to the customer.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.(b)(4).

Event Description

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

Manufacturer Narrative

The astral device was returned to resmed for an investigation.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the reported issue of device failed to charge its internal battery was due to a software issue and device failed to complete its internal self-test was due to contamination of the device pneumatic block.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference #: (b)(4).

• Brand Name: ASTRAL 150 -EUR4
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 8895800
• MDR Text Key: 154474134
• Report Number: 3004604967-2019-00257
• Device Sequence Number: 1
• Product Code: NOU
• Combination Product (y/n): N
• PMA/PMN Number: K152068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 11/07/2019

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: 07/30/2019
• Distributor Facility Aware Date: 10/13/2019
• Initial Date Manufacturer Received: 07/18/2019
• Initial Date FDA Received: 08/14/2019
• Supplement Dates Manufacturer Received: 10/13/2019
• Supplement Dates FDA Received: 11/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1