CareFusion EnVe and ReVel Ventilators Recalled for Power Connector Damage Risk
CareFusion is recalling 1,729 EnVe and ReVel ventilators because operator misconnection can damage the power connector, potentially shorting the power adapter.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "CareFusion has identified a potential for damage to the power connector on the EnVe and ReVel ventilators due to misconnection by the operator. The input port on the ventilators must have the adapters correctly aligned to function…"
Plain-English summary
CareFusion 203, Inc. is recalling 1,729 units of the EnVe and ReVel ventilators. These devices are designed for patients requiring respiratory support or mechanical ventilation and are used in hospital, transport, and homecare settings. The recall was initiated because the company identified a potential for damage to the power connector due to misconnection by the operator.
The input port on these ventilators requires adapters to be correctly aligned to function properly. If the alignment is incorrect, the pins in the connector may bend. This bending can cause the PTV AC power adapter and/or the PTV Auto Lighter Power Cord to be shorted. The affected units were distributed nationwide, including in states such as Alabama, Arizona, California, and Texas.
Healthcare facilities and users should check their serial numbers against the list provided by the manufacturer to determine if their unit is affected. If a unit is included in the recall, it should be removed from service and returned to CareFusion for repair or replacement according to the company's instructions.
The recalled product
- Product
- CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs.). It is suitable for service in hospital, transport and homecare as a source of…
- Manufacturer
- CareFusion 203, Inc.
- Category
- Medical Device — Ventilator
- Affected units
- 1,729
Distribution
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