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U.S. Department of Health and Human Services

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

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RESMED LTD ASTRAL EXTERNAL BATTERY, AMERICAS Back to Search Results
Model Number 27919
Device Problem Premature Discharge of Battery (1057)
Patient Problem No Consequences Or Impact To Patient (2199)
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. (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, AMERICAS
Manufacturer (Section D)
RESMED LTD
1 elizabeth macarthur drive.
bella vista
sydney, nsw 2153
AU 2153
Manufacturer (Section G)
RESMED LTD
1 elizabeth macarthur drive.
bella vista
sydney, nsw 2153
AU 2153
Manufacturer Contact
michelle hughes
1 elizabeth macarthur drive.
bella vista
sydney, nsw 2153
AU   2153
MDR Report Key8938228
MDR Text Key187395957
Report Number3004604967-2019-00277
Device Sequence Number1
Product Code CBK
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberK152068
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN
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 Number27919
Device Catalogue Number27919
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date08/08/2019
Event Location No Information
Date Manufacturer Received08/08/2019
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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