MAUDE Adverse Event Report: RESMED LTD ASTRAL 100 - AMER

Model Number 27001

Device Problem Operating System Becomes Nonfunctional (2996)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/04/2021

Event Type  malfunction  

Manufacturer Narrative

The device was received by resmed and an evaluation was performed.Review of the device data logs revealed a total power failure alarm following a critically low battery alarm that was muted.There was no fault found with the device.The device was serviced and fully tested before it was returned to the customer.Resmed reference #: (b)(4).

Event Description

It was reported to resmed that an astral device had an unresponsive touchscreen and was alarming.The device was not in patient use when the reported event occurred.

• Brand Name: ASTRAL 100 - AMER
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 11653574
• MDR Text Key: 245096598
• Report Number: 3007573469-2021-00488
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00619498270019
• UDI-Public: (01)00619498270019(11)180730(10)1322138
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 27001
• Device Catalogue Number: 27001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/12/2021
• Distributor Facility Aware Date: 03/19/2021
• Device Age: 31 MO
• Date Report to Manufacturer: 04/12/2021
• Date Manufacturer Received: 03/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1