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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESMED LTD ASTRAL EXTERNAL BATTERY, ROW

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RESMED LTD ASTRAL EXTERNAL BATTERY, ROW Back to Search Results
Model Number 27918
Device Problem Premature Discharge of Battery (1057)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

The device was returned to resmed and an evaluation confirmed the complaint. The internal battery was replaced to address the issue. The device was serviced and fully tested before it was returned to the customer. Resmed's risk analysis for this failure mode concludes that the risk is acceptable. Resmed reference #: (b)(4).

 
Event Description

It was reported to resmed that an astral devie had an internal 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 EXTERNAL BATTERY, ROW
Manufacturer (Section D)
RESMED LTD
1 elizabeth macarthur drive.
bella vista
sydney, nsw 2153
AU 2153
MDR Report Key9288391
MDR Text Key183952250
Report Number3007573469-2019-00349
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 11/06/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/06/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number27918
Device Catalogue Number27918
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/06/2019
Distributor Facility Aware Date10/10/2019
Device Age17 mo
Event Location No Information
Date Report TO Manufacturer11/06/2019
Date Manufacturer Received10/10/2019
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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