Medical Device Removed from Market Due to Life Threatening Manufacturing Error
This May Ventlab LLC. in Grand Rapids, Michigan, initiated a
voluntary recall of resuscitator bags after discovering that the duckbill valve
was sticking thereby preventing air to pass through the patient valve. The bags
affected could be life threatening if used, as the lack of airflow could result
in patient hypoxia and hypoventilation.
The product defect is thought to be due to incomplete curing
during the manufacturing process. This error only effects certain lots and the
full list of suspected failed lots can be found at:
Manufacturing errors such as incomplete curing are not an
unusual failure, however they have dire consequences. There have been 31
reports of delayed medical care due to professionals having to use two or three
of the resuscitation devices to assist a patient. There has also be one
reported injury due to the defective bags.
Especially when it comes to medical devices, product defects
and failures are of the utmost concern. Companies must take immediate action to
not only remove the defective product from the market, but also to solve the
production error by finding the source of the product defect. When this occurs
the manufacturer is often unable to identify the cause of the failure and must
consult expert help to pin point the defect source.
Avomeen Analytical Services provides exceptional product
failure analysis. Utilizing state-of-the-art instrumentation and methodology
our scientists examine products at the elemental level to isolate contaminants,
compare good vs. batches of product, and determine the source of a
manufacturing failure. These services help companies such as Ventlab identify
and address their problem, allowing them to quickly resume production and sale
of their medical devices.
More information regarding Avomeen’s Product Defect/Failure
Analysis can be found on our website at:
For immediate assistance with product analysis call us at 800-930-5450
or email Scientist@avomeen.com
We look
forward to working with you to solve your complex production problems!
Admin @ 1:22 PM
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