MAUDE Adverse Event Report: RESMED LTD STELLAR 100 - ASIA PAC G3; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT (FACILITY USE)

Model Number 24168

Device Problem Gas/Air Leak (2946)

Patient Problem Low Oxygen Saturation (2477)

Event Date 08/13/2023

Event Type  Injury  

Manufacturer Narrative

Resmed has requested for the device to be returned 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 reportable event occurred outside the us.During a routine check of complaints records it was detected that the event is reportable in the us.This report is being submitted to correct the error.Resmed reference#: (b)(4).

Event Description

It was reported to resmed that a patient experienced desaturation of oxygen during use of a stellar 100 device allegedly due to a leak from the oxygen connector port of the device.

• Brand Name: STELLAR 100 - ASIA PAC G3
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT (FACILITY USE)
• Manufacturer (Section D): RESMED LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 17993279
• MDR Text Key: 326350681
• Report Number: 3007573469-2023-00600
• Device Sequence Number: 1
• Product Code: MNT
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/23/2023

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: Health Professional
• Device Model Number: 24168
• Device Catalogue Number: 24168
• Device Lot Number: 1573646
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/23/2023
• Distributor Facility Aware Date: 09/20/2023
• Device Age: 22 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/23/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/23/2023
• Date Device Manufactured: 11/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Male