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

Model Number 27074

Device Problem Connection Problem (2900)

Patient Problems Cardiac Arrest (1762); Coma (2417); Respiratory Arrest (4461)

Event Date 02/11/2021

Event Type  Death  

Manufacturer Narrative

The device was returned to resmed for an extensive engineering investigation.The investigation methods, results and conclusion are not finalized at this stage.When more information is available, a supplemental report will be submitted.Resmed reference#: (b)(4).

Event Description

It was reported to resmed that a patient using an astral 150 device went into cardiopulmonary arrest, was admitted to intensive care unit in a coma and subsequently expired following a circuit disconnection alarm.

Event Description

It was reported to resmed that a patient using an astral 150 device went into cardiopulmonary arrest, was admitted to intensive care unit in a coma and subsequently expired following a circuit disconnection alarm.

Manufacturer Narrative

The astral device was returned to resmed for an investigation.Review of the device data logs confirmed the occurrence of circuit disconnection alarms.The investigation determined that there was no fault found with the returned device.The device was performing to specifications.Resmed¿s risk associated with use of the device remains acceptable.Resmed reference#: (b)(4).

• Brand Name: ASTRAL 150 DBL KIT FRA
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 11499694
• MDR Text Key: 240274633
• Report Number: 3007573469-2021-00392
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Date Returned to Manufacturer: 02/24/2021
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/29/2021
• Distributor Facility Aware Date: 03/30/2021
• Device Age: 24 MO
• Event Location: Home
• Date Report to Manufacturer: 04/29/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/16/2021
• Supplement Dates Manufacturer Received: 03/30/2021
• Supplement Dates FDA Received: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 37 YR