Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 150 - 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 150 - DEU Back to Search Results
Model Number 27053
Device Problem Inappropriate or Unexpected Reset (2959)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/20/2020
Event Type  malfunction  
Manufacturer Narrative
The device was received by resmed and an evaluation was performed.The reported failure could not be reproduced or confirmed during evaluation.The device was serviced, cleaned, calibrated and tested before it was returned to the customer.Resmed reference#: (b)(4).
 
Event Description
It was reported to resmed that an astral device underwent an unexpected restart.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 Name
ASTRAL 150 - DEU
Manufacturer (Section D)
RESMED LTD
1 elizabeth macarthur drive
bella vista
sydney, nsw 2153
AS  2153
MDR Report Key11467871
MDR Text Key239402673
Report Number3007573469-2021-00383
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
Report Date 03/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number27053
Device Catalogue Number27053
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/11/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/11/2021
Distributor Facility Aware Date02/10/2021
Device Age75 MO
Date Report to Manufacturer03/11/2021
Date Manufacturer Received02/10/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/04/2014
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
-
-