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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESMED LTD ASTRAL BATTERY PACK

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RESMED LTD ASTRAL BATTERY PACK Back to Search Results
Model Number 19620
Device Problems Premature Discharge of Battery (1057); Battery Problem (2885)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/17/2020
Event Type  Malfunction  
Manufacturer Narrative

The device was returned to resmed and an evaluation confirmed the complaint. The internal battery was replaced to address this issue. The device was serviced and fully tested before it was returned to the customer. (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 BATTERY PACK
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 Key10053224
MDR Text Key191254292
Report Number3004604967-2020-00595
Device Sequence Number1
Product Code CBK
Combination Product (Y/N)N
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,Followup
Report Date 01/04/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/13/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number19620
Device Catalogue Number19620
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/17/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date12/08/2020
Event Location No Information
Date Manufacturer Received12/08/2020
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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