MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 - FUKUDA

Model Number 27093

Device Problem Operating System Becomes Nonfunctional (2996)

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

Event Date 09/06/2021

Event Type  malfunction  

Manufacturer Narrative

The device was returned to an authorized resmed third party service center and an evaluation confirmed the complaint.The top case was replaced to address this issue.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.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 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 returned to resmed for an investigation.Performance testing confirmed the reported complaint.Visual inspection of the top case revealed a crack.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the reported complaint was due to physical damage.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference#: (b)(4).

• Brand Name: ASTRAL 150 - FUKUDA
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 12593858
• MDR Text Key: 276680432
• Report Number: 3007573469-2021-01035
• Device Sequence Number: 1
• Product Code: NOU
• UDI-Device Identifier: 00619498270934
• UDI-Public: (01)00619498270934(10)1516089
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 27093
• Device Catalogue Number: 27093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/18/2022
• Distributor Facility Aware Date: 12/22/2021
• Device Age: 6 MO
• Date Report to Manufacturer: 01/18/2022
• Date Manufacturer Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1