• 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 - AMER2

  • 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 - AMER2 Back to Search Results
Model Number 27007
Device Problem Premature Discharge of Battery (1057)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/04/2020
Event Type  Malfunction  
Manufacturer Narrative

The device was returned to an authorized resmed third party service center for an evaluation and service. The customer was issued with a replacement battery pack. (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 100 - AMER2
Manufacturer (Section D)
RESMED LTD
1 elizabeth macarthur drive.
bella vista
sydney, nsw 2153
AU 2153
Manufacturer (Section G)
RESMED LTD
1 elizabeth macarthur drive.
bella vista
sydney, nsw 2153
AU 2153
Manufacturer Contact
michelle hughes
1 elizabeth macarthur drive.
bella vista
sydney, nsw 2153
AU   2153
MDR Report Key10944189
MDR Text Key220223799
Report Number3004604967-2020-01150
Device Sequence Number1
Product Code CBK
Combination Product (Y/N)N
Reporter Country CodeBR
PMA/PMN NumberK152068
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 12/03/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/04/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number27007
Device Catalogue Number27007
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Distributor Facility Aware Date11/04/2020
Event Location No Information
Date Manufacturer Received11/04/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-