MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 - AMER; VENTILATOR, CONTINUOUS (FACILITY/HOME)

Model Number 27003

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Protective Measures Problem (3015); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 11/21/2022

Event Type  Death  

Event Description

It was reported to resmed that a patient expired while using an astral device allegedly due to device function.No further information has been made available to resmed.

Manufacturer Narrative

Resmed has requested for the device to be returned so that an engineering investigation could be performed.The device has not been returned, therefore resmed is unable to confirm the alleged malfunction at this time.If further information becomes available, a supplementary report will be submitted.Resmed reference#: (b)(4).

Manufacturer Narrative

The astral device was returned to resmed for an investigation.The device passed all performance tests and the device was performing to specifications on the date of the reported event.Review of device data logs revealed, on the day prior to the reported event, the device was manually stopped, placed in standby mode and displayed an error message (sf74) related to the software while the device was not in use on a patient.Sf74 is due to an intermittent connection with the expiratory flow sensor and is not related to the reported event.Ventilation was restarted on the day prior to the event and continued until ventilation was manually stopped on the date of the reported event.There is no evidence that the device malfunctioned on the date of the reported event.The investigation concluded that there is no relevance between the reported event and the device.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 expired while using an astral device allegedly due to device function.No further information has been made available to resmed.

• Brand Name: ASTRAL 150 - AMER
• Type of Device: VENTILATOR, CONTINUOUS (FACILITY/HOME)
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 15996734
• MDR Text Key: 305618913
• Report Number: 3007573469-2022-00829
• Device Sequence Number: 1
• Product Code: NOU
• UDI-Device Identifier: 00619498270033
• UDI-Public: (01)00619498270033(11)220126(10)1591278
• 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,Followup
• Report Date: 06/03/2023

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 27003
• Device Catalogue Number: 27003
• Device Lot Number: 1591278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/03/2023
• Distributor Facility Aware Date: 04/13/2023
• Device Age: 9 MO
• Date Report to Manufacturer: 06/03/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/16/2022
• Supplement Dates Manufacturer Received: 04/13/2023
• Supplement Dates FDA Received: 06/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 9 YR
• Patient Sex: Male
• Patient Weight: 47 KG