The U.S. Food and Drug Administration (FDA) announced a class I recall of over 100 lot numbers of CareFusion 203 ventilators after a power connection failure was observed in over 250 incidents. Reports list EnVe and ReVel models losing power and shutting off caused by a misalignment of pins where the external power connector meets the input port of the ventilator.
According to the recall notice, the misalignment could cause damage to the pins on the connector and potentially cause a short circuit, which could then prevent the internal battery from recharging and result in an unexpected loss of power. In turn, serious injury or death could result.
Medical professionals, including hospitals and equipment suppliers, were sent a product recall notice earlier this year identifying the lot numbers affected by the recall, which were distributed between December 10, 2010 and August 6, 2014. Device owners should have received a replacement power adapter accessory kits to fix the problem.
Medical device manufacturer’s have a responsibility to report defective products that they develop but consumers can also be proactive in identifying and reporting defective or dangerous medical device. If you think the product you’re using is functioning improperly, it’s wise to:
- Check the manufacturer or FDA website for any recalls.
- Make note of the irregular performance of the product.
- List any injuries it has caused.
- Fill out a MedWatch Consumer Voluntary Reporting Form.