MAUDE Adverse Event Report: RESMED LTD STELLAR 100 - UK; VENTILATOR, CONTINUOUS (FACILITY/HOME)

Model Number 24155

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Respiratory Distress (2045)

Event Type  malfunction  

Manufacturer Narrative

The device was returned to resmed for an extensive engineering investigation.The investigation methods, results, and conclusion are not finalized at this stage.(b)(4).

Event Description

It was reported to resmed that a stellar device displayed an error message (sf7).The patient experienced desaturation and had to be manually ventilated.There was no patient injury reported as a result of this incident.

Manufacturer Narrative

The stellar device was returned to resmed for an extensive engineering investigation.Review of the device data logs confirmed the occurrence of system failure 7 and over pressure alarms.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the reported system failure 7 was most likely due to water ingress and the over pressure alarm was due to a software issue.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference #: (b)(4).

Manufacturer Narrative

The stellar device was returned to resmed for an extensive engineering investigation.Review of the device data logs confirmed the occurrence of system failure 7 indicating a pressure sensor issue.Prior to the event, multiple warning alarms were triggered on the device.Performance testing could not reproduce the reported system fault 7.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the reported system failure 7 was most likely due to water ingress affecting the patient's circuit.Note: the stellar device user guide under contraindications states that "the stellar is contraindicated in patients who are unable to endure a brief interruption in ventilation.The stellar is not a life support ventilator." resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference #: (b)(4).

• Brand Name: STELLAR 100 - UK
• Type of Device: VENTILATOR, CONTINUOUS (FACILITY/HOME)
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista, nsw 2153 ; AS 2153
• Manufacturer Contact: david duley ; 9001 spectrum center blvd; san diego, CA 92123 ; 8588365985
• MDR Report Key: 6716368
• MDR Text Key: 80115352
• Report Number: 3004604967-2017-00977
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K122715
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 09/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 24155
• Device Catalogue Number: 24155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/06/2017
• Device Age: 48 MO
• Date Manufacturer Received: 08/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention