The company settled with the U.S. Department of Justice over claims that it substituted the components of its Intellivue MP2 mobile patient monitoring device that it sold to military purchasers without rectifying the device for military airworthiness.
A Philips spokesperson said that, among the company’s discussions with DOJ, it reached the final stages of settlement discussions regarding three separate matters, all of which are related to its connected care portfolio. This is the first of the three settlements to have been announced.
Despite their relation to the connected care portfolio, none of the three settlement discussions are related to the June 2021 Philips Respironics recall, for which the company is also in talks with DOJ.
According to a DOJ news release, from Jan. 1, 2012, through Nov. 27, 2018, Philips sold the MP2 devices to the U.S. Air Force, U.S. Army, U.S. Navy and the Defense Logistics Agency. The agencies require airworthiness and safe-to-fly testing and certification on medical devices used in certain aircraft environments. Such testing by military agencies ensures that a device does not adversely affect the operation of aircraft systems while conversely confirming that the aircraft does not adversely affect the proper operation and efficacy of the medical equipment.
In the settlement agreement, Philips admits that after receiving initial airworthiness and safe-to-fly certifications for the MP2 from the U.S. Army in 2008 and the U.S. Air Force in 2011, the company made modifications to the MP2 but did not adequately notify the relevant military testing facilities to determine whether the modifications required retesting for certification.
The outcome was civil claims from the U.S. alleging that Philips submitted/caused the submission of false claims to the U.S. military.
“In agreeing to this settlement, Philips acknowledges that it did not adequately notify the relevant military certifying facilities to determine whether the device modifications would or would not require retesting to maintain military airworthiness and safe-to-fly certifications,” the Philips spokesperson wrote.