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U.S. Department of Health and Human Services

Class 1 Device Recall Stellar 150

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  Class 1 Device Recall Stellar 150 see related information
Date Initiated by Firm December 12, 2019
Create Date February 07, 2020
Recall Status1 Open3, Classified
Recall Number Z-0915-2020
Recall Event ID 84551
510(K)Number K122715  
Product Classification Ventilator, continuous, minimal ventilatory support, facility use - Product Code MNT
Product ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150
Code Information Serial Number Range: 20160123307 to 22171057208
Recalling Firm/
Manufacturer
ResMed Ltd.
1 Elizabeth Macarthur Dr
Bella Vista Australia
For Additional Information Contact Sheila Bruschi
858-836-5934
Manufacturer Reason
for Recall
Combination of software and a component failure may cause audible alarms not to operate properly, the alarm buzzer not work, for ventilators that have a failed electronic component and, that are stored without AC power connected for more than 36 hours leading to full depletion of the battery and, that powers on automatically when connected to AC power without pressing the power switch.
FDA Determined
Cause 2
Device Design
Action On 12/12/19, Urgent Field Safety Notifications were emailed to customers reinforcing user instructions. Use should be consistent with indications for use. Perform a functional test including alarms as described in the "Starting therapy" section in the User guide prior to each use. Press the power switch at the back of the device once to turn on the device. Check that the alarm sounds a test beep and the LEDs (visual indicator) for the alarm signal and the Alarm mute button flash. The firm is developing a device correction to address this issue. When this is available the firm will contact affected customers with specific actions at that time. Actions to be taken by healthcare professionals and users: The device is contraindicated in patients who are unable to endure more than brief interruptions in ventilation. It is important to assess changes in a patient's dependence on mechanical ventilation, particularly if their condition is progressive. If a patient is ventilator dependent, consider consulting their physician to discuss changing the patient to an appropriate device such as a life support device. Please continue to follow all patient and device information in the User and Clinical Guides, in particular, the following sections: Performing a functional test, Working with alarms, Internal battery, and Mobile use. As always, if there are any concerns regarding device behavior and operation, please contact your local customer service contact to organize a service. Actions to be taken by distributors and healthcare providers: Please forward this notice to your affected customers and physicians. For any questions, please call (855) 245-4640.
Quantity in Commerce 69
Distribution U.S.: PA, MA, VA, TN, CT, IL, GA, FL, MT
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MNT and Original Applicant = RESMED GERMANY INC.
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