MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 DBL KIT FRA

Model Number 27074

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 09/24/2020

Event Type  Death  

Manufacturer Narrative

The two devices were taken into police custody and not returned to resmed for evaluation.No further information has ben made available to resmed at this time.If more information becomes available, a supplemental report will be submitted.(b)(4).

Event Description

It was reported to resmed that a patient was found expired while using an astral device.The patient had been using two astral devices.No further information has been made available to resmed at this time.

Manufacturer Narrative

The astral device was returned to resmed for an investigation.The investigation determined that there was no fault found with the returned device.The device was performing to specifications.Review of the device data logs revealed device warning alarms triggered as designed prior to the device powered down while using its internal battery due to depletion of the internal battery.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the reported complaint was due to user error.Resmed¿s risk associated with use of the device remains acceptable.Resmed reference#: (b)(4).

Event Description

It was reported to resmed that a patient was found expired while using an astral device.The patient had been using two astral devices.No further information has been made available to resmed at this time.

• Brand Name: ASTRAL 150 DBL KIT FRA
• 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 ; AS 2153
• Manufacturer Contact: michelle hughes ; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 10749653
• MDR Text Key: 213498659
• Report Number: 3004604967-2020-01029
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K172875
• 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,Followup
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 27074
• Device Catalogue Number: 27074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/17/2021
• Date Manufacturer Received: 05/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Sex: Male