• 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 - AMER

  • 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 - AMER Back to Search Results
Model Number 27003
Device Problem Premature Discharge of Battery (1057)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/02/2020
Event Type  Malfunction  
Manufacturer Narrative

The device was received by resmed and an evaluation was performed. The reported failure could not be reproduced during evaluation and the device operated per specifications. 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 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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameASTRAL 150 - AMER
Manufacturer (Section D)
RESMED LTD
1 elizabeth macarthur drive.
bella vista
sydney, nsw 2153
AU 2153
MDR Report Key10209218
MDR Text Key196991526
Report Number3007573469-2020-00701
Device Sequence Number1
Product Code CBK
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 06/29/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/29/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number27003
Device Catalogue Number27003
Device LOT Number1426234
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/18/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/29/2020
Distributor Facility Aware Date06/02/2020
Device Age5 mo
Event Location No Information
Date Report TO Manufacturer06/29/2020
Date Manufacturer Received06/02/2020
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

-
-