RT’s Three Key Takeaways:
- Formaldehyde Publicity Danger: Breas Medical recognized a possible short-term improve in formaldehyde publicity from new Vivo 45 LS ventilators, which might trigger airway irritation, bronchial asthma, or different severe well being points, significantly in pediatric sufferers.
- Revised Use Directions: The corporate issued up to date tips, together with reducing the utmost room temperature to be used to 30°C and requiring a 14-day pre-run interval for brand new or unused gadgets earlier than affected person use.
- No Reported Accidents: Though no accidents or deaths have been reported, the FDA has categorised the recall as severe as a result of potential dangers posed by the ventilators.
Breas Medical is updating use directions for Vivo 45 LS ventilators after inner testing of the ventilator recognized the potential for a short-term improve in formaldehyde publicity for individuals utilizing new ventilators for the primary time.
Using affected merchandise and short-term publicity to formaldehyde emissions could trigger severe adversarial well being penalties, particularly in small pediatric sufferers, that embrace short-term, reversible airway irritation or irritation resulting in airway points corresponding to bronchial asthma, and dying.
There have been no reported accidents. There have been no experiences of dying.
The Vivo 45 LS ventilator is meant to supply steady or intermittent ventilatory help for individuals who require mechanical air flow to help their respiratory. The ventilator is used for pediatric sufferers weighing greater than 5 kg by way of adults (mouthpiece air flow for adults solely). Vivo 45 LS ventilators are utilized in properties and well being care settings in addition to serving as moveable ventilators for wheelchairs and gurneys.
This recall includes updating directions for utilizing gadgets and doesn’t contain eradicating them from the place they’re used or offered. The US Meals and Drug Administration has recognized this recall as essentially the most severe kind. This system could trigger severe harm or dying.
Affected Product
- Product identify: Vivo 45 LS (US model)
- Distinctive system identifier (UDI)/Mannequin: 07321822300004/230000
- Serial numbers/manufacturing dates: D *****, F *****, Okay *****, M *****, N01 *** – N270030 Manufacturing dates as much as and together with “240530” (Could 30, 2024)
What to Do
Comply with all updates and additions to the Vivo 45 LS directions to be used, which embrace:
- Use Vivo 45 LS solely at most room air temperature of 30°C (beforehand 40°C) or much less.
- Earlier than affected person use, “pre-run” all new gadgets (distributed on or earlier than July 24, 2024) for a minimum of 14 days in an ambient room temperature of a minimum of 20°C (68°F) in the event that they haven’t been used within the final 14 days.
- Or as a substitute of performing a pre-run, contact Breas Medical Service or the native service consultant to obtain a ready-to-use substitute Vivo 45LS. This will probably be a brand new, unused system that has already been pre-run for 14 days previous to cargo.
On Aug 5, Breas Medical despatched all affected prospects an pressing medical system correction.
Clients within the US with questions on this recall ought to contact their native service consultant or Breas Medical at 855-436-8724 ext. 110 or e-mail [email protected].
Picture caption: Vivo 45 LS
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