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U.S. Department of Health and Human Services

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

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RESMED LTD ASTRAL EXTERNAL BATTERY, AMERICAS Back to Search Results
Model Number 27919
Device Problems Premature Discharge of Battery (1057); Battery Problem (2885)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Resmed has requested for the device to be returned so that an engineering investigation could be performed. The device has not yet been returned, therefore resmed is unable to confirm the alleged malfunction at this time. (b)(4).
 
Event Description
It was reported to resmed that an astral device external battery was not holding charge for more than 5 hours. There was no patient injury reported as a result of this incident.
 
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Brand NameASTRAL EXTERNAL BATTERY, AMERICAS
Manufacturer (Section D)
RESMED LTD
1 elizabeth macarthur drive.
bella vista
sydney 2153
AU 2153
Manufacturer (Section G)
RESMED CORP
9001 spectrum center blvd
san diego CA 92123
Manufacturer Contact
david duley
9001 spectrum center blvd
san diego, CA 92123
MDR Report Key6457855
MDR Text Key71832901
Report Number3004604967-2017-00411
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133868
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 04/04/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/04/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number27919
Device Catalogue Number27919
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date03/07/2017
Device Age19 MO
Event Location No Information
Date Manufacturer Received03/07/2017
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

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