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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESMED LTD ASTRAL EXTERNAL BATTERY, ROW

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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 Type  malfunction  
Manufacturer Narrative
The device is currently being returned to resmed for an extensive engineering investigation. The investigation methods, results, and conclusion are not finalized at this stage. (b)(4).
 
Event Description
It was reported to resmed that an astral device had an internal battery with reduced autonomy. There was no patient injury reported as a result of this incident.
 
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Brand NameASTRAL EXTERNAL BATTERY, ROW
Manufacturer (Section D)
RESMED LTD
1 elizabeth macarthur drive.
bella vista
sydney, nsw 2153
AU 2153
Manufacturer (Section G)
RESMED CORP
9001 spectrum center blvd
san diego CA 92123
Manufacturer Contact
ariana beck
9001 spectrum center blvd
san diego, CA 92123
MDR Report Key7301923
MDR Text Key101171397
Report Number3004604967-2018-00348
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
PMA/PMN Number
K152068
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup
Report Date 10/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number27918
Device Catalogue Number27918
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/02/2018
Was the Report Sent to FDA?
Distributor Facility Aware Date09/27/2018
Device Age18 MO
Event Location No Information
Date Manufacturer Received09/27/2018
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

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