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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 Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

The device was received by resmed and an evaluation was performed. The reported complaint could not be reproduced during evaluation. The device was serviced, cleaned, calibrated and tested before it was returned to the customer. Resmed's risk analysis for these failure modes concludes that the risk is acceptable. Resmed reference #: (b)(4).

 
Event Description

It was reported to resmed that an astral device had an internal battery with a reduced level of capacity. There was no patient harm or 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 Key8938222
MDR Text Key156458520
Report Number3007573469-2019-00275
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 08/27/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/27/2019
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? Device Returned To Manufacturer
Date Returned to Manufacturer08/13/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/27/2019
Distributor Facility Aware Date08/07/2019
Device Age29 mo
Event Location Home
Date Report TO Manufacturer08/27/2019
Date Manufacturer Received08/07/2019
Was Device Evaluated By Manufacturer? Yes
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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