Update on Vivo 45LS Use Instructions: Breas Makes Ventilator Corrections

Update on Vivo 45LS Use Instructions: Breas Makes Ventilator Corrections

Update on Vivo 45LS Use Instructions: Breas Makes Ventilator Corrections

This recall pertains to the revised usage instructions for devices and does not necessitate their removal from circulation. The FDA has categorized this recall as the highest level of concern. There is a risk of serious injury or even death if the device continues to be used.

Photo of: Vivo 45 LS (U.S. version)

Affected Product

  • Product Names: Vivo 45 LS (U.S. version)
  • Unique Device Identifier (UDI)/Model: 07321822300004/230000
  • Serial Numbers/Manufacturing Dates: D *****, F *****, K *****, M *****, N01 *** – N270030 Manufacturing dates up to and including “240530” (May 30th, 2024)

What to Do

Follow the updated Vivo 45 LS Instructions for Use, which include:

  • Utilize Vivo 45 LS only in environments where the maximum room temperature is 30°C (previously 40°C).
  • Before using any new devices (distributed on or before July 24, 2024), perform a “pre-run” in a minimum ambient room temperature of 20°C (68°F) for a duration of at least 14 days if they have been unused for the last 14 days.
    • Alternatively, you may contact Breas Medical Service or your local Service Representative to obtain a ready-to-use replacement Vivo 45LS, which will be a new, unused device that has been pre-run for 14 days prior to delivery.

On August 5, 2024, Breas Medical communicated an Urgent Medical Device Correction to all impacted customers, advising of further necessary actions:

Actions for Customers/Users

  • Operate the device at a maximum room temperature of 30°C (previously 40°C), following the identification of increased formaldehyde levels when used at higher temperatures.
  • “Pre-run” any Vivo 45 LS devices that were distributed on or before July 24, 2024, that are new or have not been used in the past two weeks, for at least 14 days at a room temperature of no less than 20°C (68°F).
    • This pre-run can be conducted in any ventilation mode (e.g. CPAP at 4 cmH2O).
    • Ensure that the air outlet of the device remains unobstructed.
    • Set up devices to pre-run in a dedicated, well-ventilated space.
    • Limit the duration personnel spend interacting with the devices during pre-run; individuals should only be present intermittently for setup or disconnection.
    • Consider placing an air purifier with an activated charcoal filter in the room.
  • As an alternative to performing a pre-run, you may reach out to Breas Medical Service or the local Service Representative for a new, pre-run Vivo 45LS.
  • Ensure all potential users in the facility are informed regarding this safety notification and the proposed actions.
  • Keep a copy of this notification as an addendum to the Instructions for Use and for record-keeping.
  • Maintain a copy of this document with the Instructions for Use.
  • Complete and return the attached acknowledgment form to vivotechnicalsupport@breas.com.

Reason for Recall

Breas Medical is updating the operating instructions for Vivo 45 LS ventilators following internal assessments that revealed a short-term risk of elevated formaldehyde exposure for first-time users of new devices.

Usage of the affected devices and transient exposure to formaldehyde emissions could lead to serious health issues, particularly in small pediatric patients, which may include temporary and reversible airway irritation or inflammation resulting in airway complications like asthma, and in severe cases, even death.

There have been no documented injuries or deaths reported.

Device Use

The Vivo 45 LS ventilator is designed to deliver continuous or intermittent ventilatory support for individuals requiring mechanical ventilation. It is applicable for pediatric patients over 5kg and adults (adult mouthpiece ventilation only). Vivo 45 LS ventilators find use in both home and healthcare environments and are also utilized as portable devices for wheelchairs and gurneys.

Contact Information

For queries related to this recall, U.S. customers should reach out to their local service representative or contact Breas Medical Inc. service at 855-436-8724 ext. 110 or e-mail vivotechnicalsupport@breas.com.

Additional FDA Resources

Additional Company Resources

Unique Device Identifier (UDI)

The unique device identifier (UDI) is essential for tracking individual medical devices from production through distribution to patient use. It aids in precise reporting, assessment, and analysis of adverse events, allowing for quicker identification and rectification of issues.

How do I report a problem?

Healthcare professionals and consumers can report adverse reactions or quality concerns experienced with these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.