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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESMED LTD ASTRAL 100 - APAC

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RESMED LTD ASTRAL 100 - APAC Back to Search Results
Model Number 27081
Device Problems Premature Discharge of Battery (1057); Power Problem (3010)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/18/2020
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

It was reported to resmed that an astral device had a power source detection issue and an external battery with a reduced level of capacity. There was no patient harm or a serious injury reported as a result of this incident.

 
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Brand NameASTRAL 100 - APAC
Manufacturer (Section D)
RESMED LTD
1 elizabeth macarthur drive.
bella vista
sydney, nsw 2153
AU 2153
MDR Report Key10291514
MDR Text Key199468566
Report Number3007573469-2020-00744
Device Sequence Number1
Product Code CBK
Combination Product (Y/N)N
Reporter Country CodeAU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 07/17/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/17/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number27081
Device Catalogue Number27081
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/17/2020
Distributor Facility Aware Date06/18/2020
Device Age15 mo
Event Location No Information
Date Report TO Manufacturer07/17/2020
Date Manufacturer Received06/18/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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