MAUDE Adverse Event Report: RESMED LTD STELLAR 100 - GERMANY

Model Number 24151

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Respiratory Distress (2045)

Event Type  malfunction  

Manufacturer Narrative

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.Resmed reference #: (b)(4).

Event Description

It was reported to resmed (b)(6) that a patient using a stellar device had shortness of breath and sought medical attention.

Event Description

It was reported to resmed (b)(4) that a patient using a stellar device had shortness of breath and sought medical attention.

Manufacturer Narrative

The stellar device was returned to resmed for an investigation.Review of the device data logs confirmed the presence of leak when circuit disconnection alarms were triggered.The investigation determined that there was no fault found with the returned device.The device performed to specifications.Resmed's risk analysis for the use of this device remains acceptable.(b)(4).

• Brand Name: STELLAR 100 - GERMANY
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive.; bella vista; sydney, nsw 2153 ; AU 2153
• MDR Report Key: 7305026
• MDR Text Key: 101355740
• Report Number: 3004604967-2018-00354
• 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
• Type of Report: Initial,Followup
• Report Date: 06/08/2018

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 24151
• Device Catalogue Number: 24151
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 05/28/2018
• Initial Date Manufacturer Received: 02/02/2018
• Initial Date FDA Received: 02/28/2018
• Supplement Dates Manufacturer Received: 05/28/2018
• Supplement Dates FDA Received: 06/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1