Today the FDA issued and posted a Class 1 recall, the most serious, for the Puritan Bennett 840 Series Ventilator by Covidien saying a software glitch may cause the device to stop working, preventing air from reaching patients who may not be able to breathe on their own and causing serious injury or death.
“Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
This ventilator recall is for a device used in the critical care of infants, children and adults. If you are not sure what brand and model ventilator your family member is using, contact their health care professional immediately.
Covidien sent a letter to patients and physicians stating that a software update is required. The company instructed patients to continue using the Puritan Bennett 840 ventilator until the are able to install the software update in one of several ways that are available on the following website: www.PB840technicalupdate.com.
Harman Law pharmaceutical and medical device attorneys are available to consult with patients and families who experience malfunctions or defects in drugs and devices that result in injury or death. The firm also works closely with physicians to address their concerns for patient care. For more information on the current investigations, go to www.HarmanLaw.com.
The Covidien Puritan Bennett 840 Series is the most recent ventilator recall from the manufacturer. In May 2013, the HT70 Ventilator and HT780 Plus Ventilators Power Pack batteries were also the subjects of an FDA Class 1 recall. The FDA said “Use of this device on battery power may cause serious adverse health consequences, including death.”
Posted on behalf of