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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 Date 05/21/2020
Event Type  Malfunction  
Manufacturer Narrative

The device was returned to resmed and an evaluation confirmed the complaint. The battery required replacement. The customer declined service and the device was scrapped as requested. 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
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 Key10172253
MDR Text Key196214503
Report Number3004604967-2020-00676
Device Sequence Number1
Product Code CBK
Combination Product (Y/N)N
Reporter Country CodeAU
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 06/18/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/18/2020
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 Manufacturer05/31/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date05/21/2020
Event Location No Information
Date Manufacturer Received05/21/2020
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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