MAUDE Adverse Event Report: STELLAR 150 TEIJIN

Model Number 24146

Device Problem Complete Loss of Power (4015)

Patient Problem Pain (1994)

Event Date 01/13/2021

Event Type  Injury  

Manufacturer Narrative

The patient¿s ventilatory requirement is not known to resmed, however, the stellar 150 user guide provides the following indications for use: - ¿the stellar 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.¿ 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.¿ 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.Based on current available information, it is unable to be determined if the device was related to the reported event.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 using a stellar 150 device, was taken to the emergency room and hospitalized.It was reported that on the day of the incident, the device sounded an alarm, the device stopped functioning and the patient complained of pain.Further information regarding the patient¿s medical condition is not available to resmed.

Event Description

It was reported to resmed that a patient using a stellar 150 device, was taken to the emergency room and hospitalized.It was reported that on the day of the incident, the device sounded an alarm, the device stopped functioning and the patient complained of pain.Further information regarding the patient¿s medical condition is not available to resmed.

Manufacturer Narrative

The stellar device was returned to resmed for an investigation.All tests passed during performance testing of the device.Review of the device data logs did not indicate a malfunction.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.Resmed reference#: (b)(4).

• Brand Name: STELLAR 150 TEIJIN
• MDR Report Key: 11314731
• MDR Text Key: 231401388
• Report Number: 3007573469-2021-00280
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 24146
• Device Catalogue Number: 24146
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/25/2021
• Distributor Facility Aware Date: 06/08/2021
• Device Age: 44 MO
• Event Location: Home
• Date Report to Manufacturer: 06/25/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/11/2021
• Supplement Dates Manufacturer Received: 06/08/2021
• Supplement Dates FDA Received: 06/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 53 YR