18

Dec

2018

VFA – Medtronic issues voluntary field corrective action for ventilators

fda, softwarechange, voluntary

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FDA posted a Medtronic announcement today that the company is launching a voluntary field action (VFA) for a software update on Puritan Bennett 980 Ventilators.

The voluntary field corrective action is a software update to address customer feedback. The software updates the external USB Drive performance and its impact on Graphical User Interface (GUI) functionality and the labeling displayed on the GUI during ventilator use. The software update also provides additional product enhancements. Medtronic is currently updating all PB980 ventilators to this new software version at customer facilities.

The company has updated the PB980 ventilator Operator’s Manual with additional information for users. The revised manual is available at: https://www.medtronic.com/content/dam/covidien/library/us/en/product/acute-care-ventilation/PB980_Operators_Manual_EN_10077893G00.pdf External Link Disclaimer

Medtronic is advising customers that they can continue to use their PB980 ventilators, before the MR5.4 software update is installed, in accordance with institutional policies. Medtronic has not received any confirmed reports of serious adverse health consequences related to the issues this software update addresses. FDA has classified this action as a Class I recall.

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