The U.S. FDA has revealed that Medtronic’s recall of certain Puritan Bennett ventilators is Class 1—which means that using the devices could result in serious patient harm or even death.
Medtronic’s North Haven, Connecticut-based Covidien unit initiated the recall for the Puritan Bennett 980 Series Ventilator (980A1ENNISB) on Nov. 4, 2021. There were a total of 278 devices in commerce.
The reason for the recall was a manufacturing assembly error in which a capacitor within the ventilator was assembled incorrectly, which could cause the device to become inoperable during use, according to an FDA database.
In response to the issue, the firm began to notify customers of the device defect on Nov. 4. Medtronic said users should remove the affected ventilators from clinical service and quarantine the affected ventilators until a Medtronic technical service engineer inspects and replaces the affected printed circuit board assemblies.
Read the full article on Mass Device.