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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 Problem Power Problem (3010)
Patient Problem Death (1802)
Event Date 09/02/2020
Event Type  Death  
Manufacturer Narrative
Resmed has requested for the device to be returned so that an engineering investigation could be performed.The device has not been returned, therefore, resmed is unable to confirm the alleged malfunction at this time.(b)(4).
 
Event Description
It was reported to resmed that a patient passed away while using an astral 150 device.It was reported that the device was found not ventilating, powered off and connected to an external battery.The incident is under police investigation.
 
Manufacturer Narrative
The astral device was not returned to resmed.Review of the device data logs showed no indication of a technical failure or indication of a device malfunction.The investigation determined that there was no fault found with the returned device.The device was performing to specifications.Resmed's risk analysis for the use of this device remains acceptable.Resmed reference#: (b)(4).
 
Event Description
It was reported to resmed that a patient passed away while using an astral 150 device.It was reported that the device was found not ventilating, powered off and connected to an external battery.The incident is under police investigation.
 
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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 Key10830367
MDR Text Key215987721
Report Number3007573469-2020-01083
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial,Followup
Report Date 01/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number27093
Device Catalogue Number27093
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/14/2021
Distributor Facility Aware Date12/16/2020
Device Age52 MO
Event Location Home
Date Report to Manufacturer01/14/2021
Date Manufacturer Received12/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
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