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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 DBL KIT FRA

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RESMED LTD ASTRAL 150 DBL KIT FRA Back to Search Results
Model Number 27074
Device Problem Device Alarm System (1012)
Patient Problem Insufficient Information (4580)
Event Date 02/02/2021
Event Type  malfunction  
Manufacturer Narrative
The device was received by resmed and an evaluation was performed.The reported failure could not be reproduced during evaluation and the device operated per specifications.The device was serviced, cleaned, calibrated and tested before it was returned to the customer.(b)(4).
 
Event Description
It was reported to resmed that an astral device failed to trigger an obstruction alarm.There was no patient harm or serious injury reported as a result of this incident.
 
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Brand Name
ASTRAL 150 DBL KIT FRA
Manufacturer (Section D)
RESMED LTD
1 elizabeth macarthur drive
bella vista
sydney, nsw 2153
AS  2153
MDR Report Key11402967
MDR Text Key234402392
Report Number3007573469-2021-00352
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
Reporter Country CodeFR
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
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number27074
Device Catalogue Number27074
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/17/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/03/2021
Distributor Facility Aware Date02/02/2021
Device Age75 MO
Date Report to Manufacturer03/03/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/03/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/14/2014
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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