MAUDE Adverse Event Report: RESMED LTD ASTRAL 100 - AMER

Model Number 27001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 12/14/2020

Event Type  Death  

Manufacturer Narrative

An investigation will be performed on all available information based on reporter¿s obligations under applicable fda regulations; however, it is likely that this matter may become the subject of litigation which may limit the company¿s ability to disclose confidential, privileged attorney client communications and work product.Investigation methods, results and conclusions are not finalized at this stage partly because the device in question has not been returned for inspection.Resmed reference #: (b)(4).

Event Description

It was reported that a patient using an astral 100 passed away.While retrieving the device, the husband told the distributor that he believed it caused his wife¿s death and was ¿no good.¿ no further information has been made available to resmed.

• Brand Name: ASTRAL 100 - AMER
• 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 ; AU 2153
• Manufacturer Contact: michelle hughes ; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 11195820
• MDR Text Key: 227597660
• Report Number: 3004604967-2021-00140
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00619498270019
• UDI-Public: (01)00619498270019(11)200806(10)1474538
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 27001
• Device Catalogue Number: 27001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/21/2020
• Date Manufacturer Received: 12/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death