Products manufactured according to substandard standards may inadvertently cause extensive injury or death to its owner, says Alabama liability attorney Keith T. Belt .
The FDA has issued a class I recall for CareFusion’s AVEA ventilators — the agency’s strictest – Class I recalls affect products with a reasonable risk of serious adverse events or death with use.
The ventilators may “develop a failure mode,” according to a company recall notice, sounding an extended high Ppeak alarm falsely, opening the device’s safety valve, and stopping treatment. That may cause serious injury or death without the intervention of a healthcare professional, an FDA statement said. The CareFusion recall is the result of 94 adverse event reports the company received — although no deaths or injuries were reported — and includes all ventilators manufactured from March 1, 2009 to June 30, 2011.
CareFusion first issued a recall notice on Sept. 15, 2011, which notified healthcare professionals of the false alarm and corrective actions by the company, as well as a warning to carefully watch patients who require therapy in the event of a malfunction. The notice stated that in the event of a safety valve release, the ventilator should be removed from use and alternate ventilation provided.
The company sent a follow-up on Oct. 4, 2011, which clarified that the device could still be used in the interim and noted that CareFusion was arranging site visits to make the necessary repairs. In an update issued on Dec. 22, the company noted that: “There is no change to the remediation plans previously announced by the company and CareFusion is actively remediating the hardware on affected units.”
The AVEA ventilator system from CareFusion is a versatile critical care ventilator for neonatal, pediatric and adult patients featuring both invasive and non-invasive applications, including infant nasal IMV. Integrated BiCore™ advanced pulmonary monitoring, Heliox administration and Volumetric Capnography give you the tools to improve your clinical outcomes. Additionally, AVEA ventilators contain a lightweight internal battery- powered compressor that facilitates patient transport within the hospital. The AVEA ventilator system has the combination of features, applications and advanced monitoring capabilities that meet your most demanding critical care ventilation needs.