MAUDE Adverse Event Report: RESMED LTD ASTRAL 100 - APAC2

Model Number 27082

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

Patient Problem Death (1802)

Event Date 12/08/2020

Event Type  Death  

Manufacturer Narrative

Resmed has requested for the device to be returned so that an engineering investigation can be performed.The device is currently in police custody and has not been returned to resmed, therefore resmed is unable to confirm the alleged malfunction at this time.Resmed reference #: (b)(4).

Event Description

It was reported to resmed that a patient using an astral 100 required cpr and subsequently expired.Allegation of device malfunction was not reported.

Event Description

It was reported to resmed that a patient using an astral 100 required cpr and subsequently expired.Allegation of device malfunction was not reported.

Manufacturer Narrative

The astral device was not returned to resmed.Review of the device data logs did not reveal any device malfunction.The investigation determined that there was no fault found with the device.An external investigation conducted by the customer at the police investigation department's request found no evidence of device malfunction.Resmed¿s risk associated with use of the device remains acceptable.Resmed reference #: (b)(4).

• Brand Name: ASTRAL 100 - APAC2
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 11136320
• MDR Text Key: 225716173
• Report Number: 3004604967-2021-00038
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K152068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 03/26/2021

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: Health Professional
• Device Model Number: 27082
• Device Catalogue Number: 27082
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/01/2021
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 01/07/2021
• Supplement Dates Manufacturer Received: 03/01/2021
• Supplement Dates FDA Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death