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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 - APAC

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RESMED LTD ASTRAL 150 - APAC Back to Search Results
Model Number 27083
Device Problems Premature Discharge of Battery (1057); Inadequate User Interface (2958)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/21/2020
Event Type  Malfunction  
Manufacturer Narrative

The device was returned to resmed and an evaluation confirmed the complaint. The internal battery and top case were 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 a faulty display and 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 150 - APAC
Manufacturer (Section D)
RESMED LTD
1 elizabeth macarthur drive
bella vista
sydney, nsw 2153
AU 2153
MDR Report Key11179969
MDR Text Key227504512
Report Number3007573469-2021-00111
Device Sequence Number1
Product Code CBK
Combination Product (Y/N)N
Reporter Country CodeAU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 01/15/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/15/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number27083
Device Catalogue Number27083
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/06/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/15/2021
Distributor Facility Aware Date12/21/2020
Device Age60 mo
Event Location No Information
Date Report TO Manufacturer01/15/2021
Date Manufacturer Received12/21/2020
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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