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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 - AMER

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RESMED LTD ASTRAL 150 - AMER Back to Search Results
Model Number 27003
Device Problem Defective Alarm (1014)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/04/2021
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. (b)(4).

 
Event Description

It was reported to resmed that an astral device was audibly alarming while displaying a red screen. The device was not in patient use when the reported event occurred.

 
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Brand NameASTRAL 150 - AMER
Manufacturer (Section D)
RESMED LTD
1 elizabeth macarthur drive
bella vista
sydney, nsw 2153
AS 2153
MDR Report Key11405508
MDR Text Key238839022
Report Number3007573469-2021-00354
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 03/03/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/03/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number27003
Device Catalogue Number27003
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/03/2021
Distributor Facility Aware Date02/04/2021
Device Age30 mo
Event Location No Information
Date Report TO Manufacturer03/03/2021
Date Manufacturer Received02/04/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured08/01/2018
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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