• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESMED LTD ASTRAL 100 DEU

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

RESMED LTD ASTRAL 100 DEU Back to Search Results
Model Number 27052
Device Problems Premature Discharge of Battery (1057); Battery Problem (2885); Inadequate User Interface (2958); Power Problem (3010)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/30/2021
Event Type  Malfunction  
Manufacturer Narrative

The device was returned to resmed and an evaluation confirmed the complaint. The top case , main circuit board and internal battery required replacement to address the issues. The device was deemed beyond repair and scrapped. Resmed reference#: pr (b)(4).

 
Event Description

It was reported to resmed that an astral device had a defective display, power source detection issue 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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameASTRAL 100 DEU
Manufacturer (Section D)
RESMED LTD
1 elizabeth macarthur drive
bella vista
sydney, nsw 2153
AS 2153
MDR Report Key11733968
MDR Text Key249954098
Report Number3007573469-2021-00546
Device Sequence Number1
Product Code CBK
Combination Product (Y/N)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 08/10/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/27/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number27052
Device Catalogue Number27052
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/30/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/10/2021
Distributor Facility Aware Date07/12/2021
Device Age67 mo
Event Location No Information
Date Report TO Manufacturer08/10/2021
Date Manufacturer Received07/12/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/12/2015
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-