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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESMED RESMED STELLAR; STELLAR RESPIRATORY ASSIST DEVICE
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RESMED RESMED STELLAR; STELLAR RESPIRATORY ASSIST DEVICE Back to Search Results
Model Number 150V 1.5
Device Problems Device Inoperable (1663); Low Battery (2584); Device Displays Incorrect Message (2591)
Patient Problem Adult Respiratory Distress Syndrome (1696)
Event Date 11/11/2016
Event Type  Injury  
Event Description
(b)(6) mother called one of our respiratory therapists, (b)(6) and stated that his stellar device was reading an error message: system failure 21.The machine would not turn on and work properly because of this error.Recommendations from the user manual for trouble shooting said to send back to the mfr for servicing.(b)(6) then took our backup stellar to their home and put on pt.The pt did fine on it, and there were no issues.The stellar device that had stopped working was sent to the mfr, resmed for servicing.
 
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Brand Name
RESMED STELLAR
Type of Device
STELLAR RESPIRATORY ASSIST DEVICE
Manufacturer (Section D)
RESMED
9001 spectrum center blvd.
san diego CA 32123
MDR Report Key6159151
MDR Text Key62098447
Report Number6159151
Device Sequence Number1
Product Code BZD
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 11/30/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number150V 1.5
Device Catalogue Number24161
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/12/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/02/2016
Distributor Facility Aware Date11/11/2016
Device Age2 YR
Event Location Home
Date Report to Manufacturer12/02/2016
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
Patient Age28 YR
Patient Weight67
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