MAUDE Adverse Event Report: RESMED LTD ASTRAL 100 - EUR4

Model Number 27061

Device Problems Premature Discharge of Battery (1057); Inadequate User Interface (2958)

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 internal battery and top case 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 had an internal battery with a reduced level of capacity and had an unresponsive touchscreen.There was no patient harm or serious injury reported as a result of this incident.

• Brand Name: ASTRAL 100 - EUR4
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• Manufacturer (Section G): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• Manufacturer Contact: michelle hughes ; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 8820043
• MDR Text Key: 152043795
• Report Number: 3004604967-2019-00232
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K152068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/24/2019

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: 27061
• Device Catalogue Number: 27061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2019
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/02/2019
• Initial Date Manufacturer Received: 07/02/2019
• Initial Date FDA Received: 07/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1