• 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 EXTERNAL BATTERY, ROW

  • 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 EXTERNAL BATTERY, ROW Back to Search Results
Model Number 27918
Device Problems Premature Discharge of Battery (1057); Battery Problem (2885)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/14/2020
Event Type  Malfunction  
Manufacturer Narrative

The device was returned to resmed and an evaluation confirmed the complaint. The battery was replaced to address this 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 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 EXTERNAL BATTERY, ROW
Manufacturer (Section D)
RESMED LTD
1 elizabeth macarthur drive.
bella vista
sydney, nsw 2153
AU 2153
MDR Report Key10053469
MDR Text Key190953237
Report Number3007573469-2020-00597
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,Followup
Report Date 07/29/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/13/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number27918
Device Catalogue Number27918
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/22/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/29/2020
Distributor Facility Aware Date07/07/2020
Device Age7 mo
Event Location No Information
Date Report TO Manufacturer07/29/2020
Date Manufacturer Received07/07/2020
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

-
-