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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 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 exchanged for a new one to address this issue. 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 device 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 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 Key9288396
MDR Text Key188736434
Report Number3004604967-2019-00347
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
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 Number19620
Device Catalogue Number19620
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date10/09/2019
Event Location No Information
Date Manufacturer Received10/09/2019
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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