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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 - AMER
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RESMED LTD ASTRAL 150 - AMER Back to Search Results
Model Number 27003
Device Problems Premature Discharge of Battery (1057); Failure to Calibrate (2440)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The device was returned to resmed and an evaluation confirmed reports of the device failing to complete its internal self test.The non-return valve (nrv) assembly was replaced to address this issue.The reported issue related to reduced battery capacity was not reproduced.The device was serviced and fully tested before it was returned to the customer.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference #: (b)(4).
 
Event Description
It was reported to resmed that an astral device had an internal battery with a reduced level of capacity and failed to complete its internal self test.There was no patient harm or serious injury reported as a result of this incident.
 
Event Description
It was reported to resmed that an astral device had an internal battery with a reduced level of capacity and failed to complete its internal self test.There was no patient harm or serious injury reported as a result of this incident.
 
Manufacturer Narrative
The astral device was returned to resmed for an investigation.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the reported battery complaint was due to a software issue.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference #: (b)(4).
 
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Brand Name
ASTRAL 150 - AMER
Manufacturer (Section D)
RESMED LTD
1 elizabeth macarthur drive.
bella vista
sydney, nsw 2153
AU  2153
MDR Report Key8714845
MDR Text Key149347020
Report Number3004604967-2019-00194
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 distributor
Type of Report Initial,Followup
Report Date 08/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number27003
Device Catalogue Number27003
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/14/2019
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/08/2019
Distributor Facility Aware Date07/10/2019
Device Age45 MO
Date Report to Manufacturer08/08/2019
Date Manufacturer Received07/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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