MAUDE Adverse Event Report: RESMED PTY LTD STELLAR 150 FRANCE; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT (FACILITY USE)

Model Number 24142

Device Problems Device Alarm System (1012); Tidal Volume Fluctuations (1634); Protective Measures Problem (3015)

Patient Problems Discomfort (2330); Respiratory Acidosis (2482); Respiratory Failure (2484); Increased Respiratory Rate (2486)

Event Date 02/19/2024

Event Type  Injury  

Manufacturer Narrative

The device was returned to resmed and an initial evaluation confirmed the reported insufficient tidal volumes.Analysis of the device error logs revealed occurrences of system failure 21/13 related to the motor.Dust contamination was visualized at the filter, filter cover, inlet assembly, flow meter and pneumatic block.The investigation conclusion is not finalized at this stage.If more information becomes available, a supplemental report will be submitted.The stellar 150 device user guide provides the following indications for use: - ¿the stellar 100/150 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.¿ resmed reference#: (b)(4).

Event Description

It was reported to resmed that a patient experienced respiratory exhaustion, tachypnea, discomfort, suffocation, hypercapnic respiratory acidosis and severe malnutrition allegedly due to "turbine failure" of a stellar 150 device with insufficient tidal volumes delivered and absence of alarm of the failure.The patient was hospitalized for re-evaluation of ventilator settings and observation of patient.The patient was removed from the device and placed on an astral device after which there was rapid improvement in patient condition.

• Brand Name: STELLAR 150 FRANCE
• Type of Device: VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT (FACILITY USE)
• Manufacturer (Section D): RESMED PTY LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• Manufacturer (Section G): RESMED PTY LTD; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• Manufacturer Contact: jaklin aziz ; 1 elizabeth macarthur drive; bella vista; sydney, nsw 2153 ; AS 2153
• MDR Report Key: 19076057
• MDR Text Key: 339774368
• Report Number: 3004604967-2024-00099
• Device Sequence Number: 1
• Product Code: MNT
• UDI-Device Identifier: 00619498241422
• UDI-Public: (01)00619498241422(10)1517216
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 04/09/2024

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: Lay User/Patient
• Device Model Number: 24142
• Device Catalogue Number: 24142
• Device Lot Number: 1517216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2024
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/11/2024
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 42 KG