Philips IntelliVue MP2 (Patient Monitor)

2022: US fines Philips for providing false information about patient monitors

On August 30, 2022, Philips announced that it had reached an agreement with the US Department of Justice for $4.2 million under the False Information Act regarding the IntelliVue MP2 mobile patient monitoring monitor.

A Philips spokesman said that during the company's negotiations with the US Department of Justice, it reached the final stage of discussing the settlement of three separate issues, each related to its products in the field of medical monitoring systems. This is the first of three settlements to be announced.

US fines Philips

Despite their connection to the range of medical monitoring systems, none of the three settlement negotiations are related to the June 2021 recall of Philips Responics, for which the company is also negotiating with the Ministry of Justice.

According to a press release from the Ministry of Justice, from January 1, 2012 to November 27, 2018, Philips sold MP2 devices to the US Air Force, the US Army, the US Navy and the Defense Logistics Agency. These agencies require testing and certification for airworthiness and safety for flights with respect to medical devices used in certain aircraft operating conditions. Such tests carried out by the military departments ensure that the operation of the device will not be adversely affected by the operation of the aircraft systems, and, conversely, confirm that the aircraft does not adversely affect the proper operation and effectiveness of medical equipment.

Under the agreement, Philips received initial airworthiness and flight safety certificates for monitors from the Army in 2008 and from the Air Force in 2011. Philips later made changes to the devices, but did not notify the military test centers. The result of this, according to the Ministry of Justice, was civil lawsuits by the United States, which claimed that Philips presented/caused false information to the American military.

Philips acknowledged that it had not properly notified the relevant military certification centres to determine whether repeated tests would be required to preserve airworthiness and safety certificates.

The company said it had already set up an appropriate financial reserve in connection with the settlement. Philips did not say which other two settlements reached the final stage of discussion, but said it had also created reserves in connection with those settlements.

In agreeing to this settlement, Philips acknowledges that it did not properly notify the relevant military certification centers to determine whether modified retest devices would require airworthiness and safety certificates to be maintained, a Philips spokesman wrote.[1][2]

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