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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESMED LTD ASTRAL 100 - AMER

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RESMED LTD ASTRAL 100 - AMER Back to Search Results
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.

 
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Brand NameASTRAL 100 - AMER
Manufacturer (Section D)
RESMED LTD
1 elizabeth macarthur drive
bella vista
sydney, nsw 2153
AS 2153
MDR Report Key11346130
MDR Text Key232506328
Report Number3007573469-2021-00318
Device Sequence Number1
Product Code CBK
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
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 Received02/18/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number27001
Device Catalogue Number27001
Device LOT Number1229435
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/08/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/18/2021
Distributor Facility Aware Date01/19/2021
Device Age46 mo
Event Location Home
Date Report TO Manufacturer02/18/2021
Date Manufacturer Received01/19/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/15/2017
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 02/18/2021 Patient Sequence Number: 1
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