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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STELLAR 150 EUROPE GRP1
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STELLAR 150 EUROPE GRP1 Back to Search Results
Model Number 24143
Device Problem Unexpected Therapeutic Results (1631)
Patient Problem Cardiac Arrest (1762)
Event Date 04/06/2021
Event Type  Injury  
Manufacturer Narrative
Resmed has requested return of the device so that an engineering investigation can be performed.The device has not been returned, therefore, resmed is unable to confirm the alleged malfunction at this time.The stellar 100/150 user guide provides the following indications for use: ¿the stellar 100/150 is intended to provide ventilation for non-dependent, spontaneously breathing adult and pediatric patients (13kg and above) with respiratory insufficiency, or respiratory failure, with or without obstructive sleep apnea.¿ in the event of device failure, the patient would be able to continue to breathe spontaneously until an alternative means of ventilation support can be provided.The user guide also provides the following contraindication: - ¿the stellar is contraindicated in patients who are unable to endure more than brief interruptions in ventilation.The stellar is not a life support ventilator.¿ resmed reference#: (b)(4).
 
Event Description
It was reported to resmed that a pediatric patient receiving non-invasive ventilation on a stellar 150 device went into cardiac arrest, required resuscitation and recovered.It was reported the device was in standby mode at the time of the incident, ventilation was restarted on the device after the incident and the patient continued therapy on the device.The patient subsequently expired and the death was reported as unrelated to the incident or device.
 
Event Description
It was reported to resmed that a pediatric patient receiving non-invasive ventilation on a stellar 150 device went into cardiac arrest, required resuscitation and recovered.It was reported the device was in standby mode at the time of the incident, ventilation was restarted on the device after the incident and the patient continued therapy on the device.The patient subsequently expired and the death was reported as unrelated to the incident or 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 associated with use of the device remains acceptable.The stellar 100/150 user guide provides the following indications for use: - ¿the stellar 100/150 is intended to provide ventilation for non-dependent, spontaneously breathing adult and pediatric patients (13kg and above) with respiratory insufficiency, or respiratory failure, with or without obstructive sleep apnea.¿ in the event of device failure, the patient would be able to continue to breathe spontaneously until an alternative means of ventilation support can be provided.The user guide also provides the following contraindication: - ¿the stellar is contraindicated in patients who are unable to endure more than brief interruptions in ventilation.The stellar is not a life support ventilator.¿ resmed reference#: pr 2262317.
 
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Brand Name
STELLAR 150 EUROPE GRP1
MDR Report Key11778468
MDR Text Key249095519
Report Number3004604967-2021-00570
Device Sequence Number1
Product Code MNT
Combination Product (y/n)Y
PMA/PMN Number
K122715
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup
Report Date 06/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number24143
Device Catalogue Number24143
Device Lot Number1165767
Was Device Available for Evaluation? Yes
Distributor Facility Aware Date05/12/2021
Initial Date Manufacturer Received 04/09/2021
Initial Date FDA Received05/05/2021
Supplement Dates Manufacturer Received05/12/2021
Supplement Dates FDA Received06/07/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/15/2016
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age18 MO
Patient Weight10
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