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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESMED LTD ASTRAL 100 - APAC1
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RESMED LTD ASTRAL 100 - APAC1 Back to Search Results
Model Number 27081
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 and an evaluation confirmed the complaint.The battery was replaced to address the 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 reduced level of capacity.There was no patient harm or serious injury reported as a result of this incident.
 
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Brand Name
ASTRAL 100 - APAC1
Manufacturer (Section D)
RESMED LTD
1 elizabeth macarthur drive.
bella vista
sydney, nsw 2153
AU  2153
MDR Report Key9886469
MDR Text Key188564717
Report Number3007573469-2020-00420
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number27081
Device Catalogue Number27081
Device Lot Number1190279
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/16/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/26/2020
Distributor Facility Aware Date03/02/2020
Device Age42 MO
Date Report to Manufacturer03/26/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/26/2020
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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