MAUDE Adverse Event Report: RESMED LTD ASTRAL 100 - AMER

Model Number 27001

Device Problems Battery Problem (2885); Complete Loss of Power (4015)

Patient Problems Death (1802); Insufficient Information (4580)

Event Date 12/29/2020

Event Type  Death  

Manufacturer Narrative

The astral device was returned to resmed for an investigation.Review of the device data logs revealed the occurrence of a battery degraded warning alarm and total power failure alarms.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the battery degraded warning alarm was triggered as a false alarm and due to the battery controller software.The total power failure alarms were due to depletion of battery.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference#: (b)(4).

Event Description

It was reported to resmed that a patient using an astral device passed away.It was reported the death of the patient was discovered by the customer through a newspaper obituary.

• Brand Name: ASTRAL 100 - AMER
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 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: 11346089
• MDR Text Key: 232505283
• Report Number: 3004604967-2021-00318
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00619498270019
• UDI-Public: (01)00619498270019(11)170315(10)1229435
• 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: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 27001
• Device Catalogue Number: 27001
• Device Lot Number: 1229435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/19/2021
• Date Manufacturer Received: 01/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 64 YR
• Patient Weight: 138