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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 Premature Discharge of Battery (1057)
Patient Problem No Patient Involvement (2645)
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 an internal and 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 150 - AMER
Manufacturer (Section D)
RESMED LTD
1 elizabeth macarthur drive.
bella vista
sydney, nsw 2153
AU 2153
MDR Report Key9359760
MDR Text Key184086835
Report Number3007573469-2019-00389
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 11/21/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/21/2019
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 FDA11/21/2019
Distributor Facility Aware Date10/23/2019
Event Location No Information
Date Report TO Manufacturer11/21/2019
Date Manufacturer Received10/23/2019
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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