MAUDE Adverse Event Report: RESMED LTD STELLAR 100 (0101-24151)

Model Number 2415

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

The device is currently being returned to resmed for an engineering investigation.The investigation methods, results, and conclusion are not finalized at this stage.When more information is available a supplemental report will be submitted.It was reported the patient had two stellar devices with serial numbers(b)(4).It is unknown which device was in use on the patient at the time of the reported event, therefore, two medwatch reports have been filed for the same event.Ref: (b)(4).Per the stellar user guide, the stellar is not a life support ventilator.The stellar is contraindicated in patients who are unable to endure more than brief interruptions in ventilation.Resmed reference #: (b)(4).Device received, pending evaluation.

Event Description

It was reported to resmed that a stellar device alarmed, the patient was admitted to the hospital and expired six days later due to carbon dioxide poisoning.

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.Per the stellar user guide, the stellar is not a life support ventilator.The stellar is contraindicated in patients who are unable to endure more than brief interruptions in ventilation.(b)(4).

Event Description

It was reported to resmed that a stellar device alarmed, the patient was admitted to the hospital and expired six days later due to carbon dioxide poisoning.

• Brand Name: STELLAR 100 (0101-24151)
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• Manufacturer (Section G): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• Manufacturer Contact: michelle hughes ; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 9789231
• MDR Text Key: 182108146
• Report Number: 3004604967-2020-00322
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• PMA/PMN Number: K122715
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Device Operator: Lay User/Patient
• Device Model Number: 2415
• Device Catalogue Number: 2415
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/25/2020
• Date Manufacturer Received: 03/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death