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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 Problems Premature Discharge of Battery (1057); Power Problem (3010)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/16/2020
Event Type  Malfunction  
Manufacturer Narrative

The device was returned to resmed and an evaluation confirmed the complaint. The battery was replaced to address the issue. The device was serviced and fully tested before it was returned to the customer. Resmed reference#: (b)(4).

 
Event Description

It was reported to resmed that an astral device had an external 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 EXTERNAL BATTERY, ROW
Manufacturer (Section D)
RESMED LTD
1 elizabeth macarthur drive.
bella vista
sydney, nsw 2153
AU 2153
MDR Report Key10388835
MDR Text Key202349663
Report Number3007573469-2020-00818
Device Sequence Number1
Product Code CBK
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 02/03/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/10/2020
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? Device Returned To Manufacturer
Date Returned to Manufacturer07/16/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/03/2021
Distributor Facility Aware Date01/17/2021
Device Age10 mo
Event Location No Information
Date Report TO Manufacturer02/03/2021
Date Manufacturer Received01/17/2021
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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