UPDATE TO URGENT MEDICAL DEVICE CORRECTION
November 19, 2024
Reference: CAPA-298

This notice supplements the Correction Notice originally issued by Breas Medical on August 5, 2024. In support of an increase in the maximum operating temperature of the Vivo 45 LS (US), extensive testing and analyses performed by independent laboratories and toxicologists have demonstrated tolerable toxicological risk for formaldehyde emissions after the device is operated for 21 days (or 504 hours) of run time. Accordingly, Breas is pleased to inform you that the maximum operating temperature for the Vivo 45LS may be increased from 30°C (86°F) to 40°C (104°F) once the operating time of a Vivo 45 LS device reaches 21 days (504 hours). This applies to all devices shipped prior to January 20, 2025. Additionally, all devices shipped on or after January 20, 2025, may be operated at temperatures up to 40°C (104°F) immediately upon being put into service without the need for users to perform a 21-day pre-run, as Breas will process these devices prior to shipment ensuring they meet the criteria for formaldehyde emissions.

Please retain this document as an addendum to the Instructions for Use and for your records. Please keep a copy of this document available with the Instructions for Use. Kindly ensure all potential users in your facility are made aware of this notification supplement.

How to Determine Device Operating Time:
IMPORTANT: Only perform this when the device is NOT connected to a patient.

1. Make sure the device is in Ventilator Standby mode. If the device is powered off, press the Start/Stop button and wait until the Start Up sequence is finalized (see Clinician’s/User Manual, chapter 5.1).


2. On the front panel, press navigation button labeled “Others”, just below the display (see Clinician’s/User Manual, chapter 5.2.1 – 5.2.3).


3. Press the Up button until “Device Information” is highlighted, then press the Right button (see Clinician’s/User Manual, chapter 5.2.1 – 5.2.3).


4. Device Operating Time in hours is displayed on the top row in the menu (see Clinician’s/User Manual, chapter 5.2.11.12/5.2.9.6).


5. Only applicable to devices shipped prior to January 20, 2025: If Device Operating Time is at least 504 hours, then the device has been operated for at least 21 days and can be operated at a maximum operating temperature of 40°C (104°F). If Device Operating Time is less than 504 hours, the device should be operated at a maximum operating temperature not exceeding 30°C (86°F).

Contact Information:
If you have any questions or concerns regarding this notification supplement, please contact Breas Medical, Inc. Service Department or your local Service Representative. The Breas Medical, Inc. Service Department can be reached at 855-436-8724 ext. 110 between 8.00am and 5.00pm ET Mondays through Fridays, or by e-mail at vivotechnicalsupport@breas.com.

The FDA encourages health care providers to report any adverse events or suspected adverse events experienced with any medical device. Health care personnel employed by facilities that are subject to the FDA's User Facility Reporting Requirements should follow the reporting procedures established by their facilities. Adverse events or suspected adverse event reports can be voluntarily submitted through MedWatch: The FDA Safety Information and Adverse Event Reporting program online at www.fda.gov/medwatch/report.htm.

Please be assured that maintaining a high level of safety and quality is our highest priority. If you have any questions, please contact us per the contact information above.

Sincerely,
Ivan Liljegren
Senior Vice President, Global Quality Assurance and Regulatory Affairs

COM-009342 rev.0 (supplements COM-009328 rev.3)