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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESMED LTD ASTRAL 150 - FUKUDA
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RESMED LTD ASTRAL 150 - FUKUDA Back to Search Results
Model Number 27093
Device Problems Failure to Calibrate (2440); Protective Measures Problem (3015)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The device was returned and an evaluation could not confirm the reported sf 131.The pneumatic block was replaced to address the failed to complete its internal self-test the device was serviced and fully tested before it was returned to the customer.Resmed's risk analysis for the failure mode concludes that the risk is acceptable.(b)(4).
 
Event Description
It was reported to resmed that an astral device failed to complete its internal self-test and displayed an error message (sf 131) related to the main blower temperature sensor.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.Review of the device data logs confirmed the reported sf 131.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the reported complaint was due to contamination.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 failed to complete its internal self-test and displayed an error message (sf 131) related to the main blower temperature sensor.There was no patient harm or serious injury reported as a result of this incident.
 
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Brand Name
ASTRAL 150 - FUKUDA
Manufacturer (Section D)
RESMED LTD
1 elizabeth macarthur drive.
bella vista
sydney, nsw 2153
AU  2153
MDR Report Key9373240
MDR Text Key177964394
Report Number3007573469-2019-00409
Device Sequence Number1
Product Code NOU
Combination Product (y/n)N
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 12/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number27093
Device Catalogue Number27093
Device Lot Number1308707
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/05/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/26/2019
Distributor Facility Aware Date11/27/2019
Device Age17 MO
Date Report to Manufacturer12/26/2019
Date Manufacturer Received11/27/2019
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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