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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); Power Problem (3010)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The astral device was returned to resmed for an investigation. Review of the device data logs confirmed the occurrence of the astral external battery only lasting for 4 hours. Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the root cause was an isolated component failure within the device battery assembly. Resmed's risk analysis for this failure mode concludes that the risk is acceptable. (b)(4).
 
Event Description
It was reported to resmed that an astral battery did not meet customer expectation and only lasted for 4 hours. There was no patient injury reported as a result of this incident.
 
Manufacturer Narrative
The device was returned to resmed and an evaluation was performed. The evaluation determined that the battery failing to deliver power beyond 4 hours was due to the battery. The internal battery was replaced to address this issue. Resmed's risk analysis for this failure mode concludes that the risk is acceptable. (b)(4).
 
Event Description
It was reported to resmed that an astral battery did not meet customer expectation and only lasted for 4 hours. 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 Key7037509
MDR Text Key251466995
Report Number3004604967-2017-01636
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 08/28/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/16/2017
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 Manufacturer10/19/2017
Was the Report Sent to FDA?
Distributor Facility Aware Date07/30/2018
Device Age34 MO
Event Location No Information
Date Manufacturer Received07/30/2018
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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