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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESMED LTD STELLAR 100 - GERMANY
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RESMED LTD STELLAR 100 - GERMANY Back to Search Results
Model Number 24151
Device Problem Insufficient Information (3190)
Patient Problems Fainting (1847); Low Oxygen Saturation (2477)
Event Type  Injury  
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 during use of a stellar 100 device, the patient had 4 episodes of fainting and was hospitalized.It was reported the service technician identified that oxygen saturation drops with use of the device.
 
Manufacturer Narrative
The stellar device was returned to resmed for an investigation.The investigation determined that there was no fault found with the returned device.The device was performing to specifications.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 during use of a stellar 100 device, the patient had 4 episodes of fainting and was hospitalized.It was reported the service technician identified that oxygen saturation drops with use of the device.
 
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Brand Name
STELLAR 100 - GERMANY
Manufacturer (Section D)
RESMED LTD
1 elizabeth macarthur drive.
bella vista
sydney, nsw 2153
AU  2153
MDR Report Key9650214
MDR Text Key177123876
Report Number3007573469-2020-00208
Device Sequence Number1
Product Code MNT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Type of Report Initial,Followup
Report Date 03/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number24151
Device Catalogue Number24151
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/26/2020
Distributor Facility Aware Date03/04/2020
Device Age63 MO
Date Report to Manufacturer03/26/2020
Date Manufacturer Received03/04/2020
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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