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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 Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/26/2021
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. 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 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
AS 2153
Manufacturer (Section G)
RESMED LTD
1 elizabeth macarthur drive
bella vista
sydney, nsw 2153
AS 2153
Manufacturer Contact
michelle hughes
1 elizabeth macarthur drive
bella vista
sydney, nsw 2153
AS   2153
MDR Report Key11566126
MDR Text Key243556668
Report Number3004604967-2021-00442
Device Sequence Number1
Product Code CBK
Combination Product (Y/N)N
Reporter Country CodeGM
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 03/24/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/24/2021
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 Date02/26/2021
Event Location No Information
Date Manufacturer Received02/26/2021
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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