Medtronic is notifying customers worldwide of a voluntary field corrective action—a software update—for its Puritan Bennett 980 (PB980) ventilator series. 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, Medtronic said in a statement.
The software update also provides additional product enhancement—with Medtronic currently updating all PB980 ventilators to this new software version at customer facilities. Further, the company has updated the PB980 ventilator Operator’s Manual with additional information for users, which is available here.
In the statement, Medtronic added that it 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. Fortunately, company officials say, Medtronic has not received any confirmed reports of serious adverse health consequences related to the issues this software update addresses. Even so, the U.S. FDA has classified this action as a Class I recall.
“If you are aware of any incidents related to this issue or if you have any questions, please contact our Technical Support Department immediately at 1-800-255-6774 to provide information regarding those events so regulatory reporting obligations can be fulfilled,” Medtronic said in the statement. “Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail, or by fax.”