Internal testing identified the potential for a short-term increase in formaldehyde exposure for people using new ventilators for the first time.
RT’s Three Key Takeaways:
- Formaldehyde Exposure Risk: Breas Medical identified a potential short-term increase in formaldehyde exposure from new Vivo 45 LS ventilators, which could cause airway irritation, asthma, or other serious health issues, particularly in pediatric patients.
- Revised Use Instructions: The company issued updated guidelines, including lowering the maximum room temperature for use to 30°C and requiring a 14-day pre-run period for new or unused devices before patient use.
- No Reported Injuries: Although no injuries or deaths have been reported, the FDA has classified the recall as serious due to the potential risks posed by the ventilators.
Breas Medical is updating use instructions for Vivo 45 LS ventilators after internal testing of the ventilator identified the potential for a short-term increase in formaldehyde exposure for people using new ventilators for the first time.
The use of affected products and short-term exposure to formaldehyde emissions may cause serious adverse health consequences, especially in small pediatric patients, that include temporary, reversible airway irritation or inflammation leading to airway issues such as asthma, and death.
There have been no reported injuries. There have been no reports of death.
The Vivo 45 LS ventilator is intended to provide continuous or intermittent ventilatory support for people who require mechanical ventilation to support their breathing. The ventilator is used for pediatric patients weighing more than 5 kg through adults (mouthpiece ventilation for adults only). Vivo 45 LS ventilators are used in homes and health care settings as well as serving as portable ventilators for wheelchairs and gurneys.
This recall involves updating instructions for using devices and does not involve removing them from where they are used or sold. The US Food and Drug Administration has identified this recall as the most serious type. This device may cause serious injury or death.
Affected Product
- Product name: Vivo 45 LS (US 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 30, 2024)
What to Do
Follow all updates and additions to the Vivo 45 LS instructions for use, which include:
- Use Vivo 45 LS only at maximum room air temperature of 30°C (previously 40°C) or less.
- Before patient use, “pre-run” all new devices (distributed on or before July 24, 2024) for at least 14 days in an ambient room temperature of at least 20°C (68°F) if they haven’t been used in the last 14 days.
- Or instead of performing a pre-run, contact Breas Medical Service or the local service representative to receive a ready-to-use replacement Vivo 45LS. This will be a new, unused device that has already been pre-run for 14 days prior to shipment.
On Aug 5, Breas Medical sent all affected customers an urgent medical device correction.
Customers in the US with questions about this recall should contact their local service representative or Breas Medical at 855-436-8724 ext. 110 or e-mail [email protected].
Photo caption: Vivo 45 LS
File photo
