Class I Recall Issued for Puritan Bennett 980 Ventilators
Personal Injury Lawsuit: Class I Recall Issued for Puritan Bennett 980 Ventilators
Our firm is investigating potential lawsuits on behalf of patients who suffered injuries or death related to the Puritan Bennett 980 Ventilator System (PB980), which was recalled in July 2015 because it may fail to deliver the sufficient amount of oxygen when in the neonatal Volume Control Plus (VC+) mode with active humidification. This life-threatening software defect prompted a Class I recall in July 2015 and involved about 650 ventilators.
The PB980 Ventilator System received U.S. Food and Drug Administration (FDA) clearance in February 2014 and is distributed by Covidien. In 2015, Medtronic plc acquired Covidien Ltd.
If you or someone you know suffered adverse health consequences related to the PB980 recall, contact Parker Waichman today.
PB980 May Deliver Less Air Than Programmed
The PB980 is used in hospitals or during patient transport to provide constant breathing support to adults, children, and premature babies weighing at least 10.6 ounces.
According to an FDA safety alert, a recall was issued for the PB980 on July 16, 2015. The recall was issued because the system may not appropriately deliver the amount of air programmed when in the neonatal Volume Control Plus (VC+) mode with active humidification. The alert states that “...a software error may cause the amount of air being delivered to the patient (tidal volume) to be lower than the amount programmed by the clinician.”
The FDA designated the recall a Class I. Class I recalls are the most serious type of recall; they indicate that exposure to the recalled device can lead to serious injury or death. “If a patient does not receive the amount of air set on the machine, they may need to be removed from the ventilator and placed on a different system. A patient not receiving enough oxygen, can result in possible injury or death.” the FDA alert reads.
The recall affects the following product codes: 980U1ENDIUU, 980U1ENDIUUS, 980U3ENDIUU, 980U3ENDIUUS, 980N1ENDIUU, 980N1ENDIUUS, 980N3ENDIUU, 980N3ENDIUUS. The lots were manufactured from March 2014 to June 2015 and distributed from March 1, 2014 to June 17, 2015.
Puritan Bennett 980 Ventilator System Recalled Twice
According to the FDA, Medtronic began advising hospitals in July 2015 regarding the issue involving the system’s inability to deliver sufficient oxygen when in the neonatal VC+ mode with active humidification. The Class I designation by the agency was made because the system’s inability to deliver sufficient oxygen may lead to injuries or death.
The drug maker received field reports that the VC+ mode, a specific breathing setting, may not deliver sufficient oxygen when used with another setting that humidifies the air, a setting typically used for neonatal patients. Since, Medtronic has been sending service engineers to reconfigure the PB980 devices and remove the NeoMode capability setting. Medtronic indicates that the PB980 is safe for other uses in adult and pediatric patients.
Meanwhile, in October 2014, the agency announced a Covidien recall of 324 of the PB980 ventilators. At that time, the agency’s notice indicated that ventilators with older software versions may have a defect that would cause the machine to stop working should air and oxygen supply lines be disconnected and reattached. “This can lead to serious health problems or death if the health care provider does not connect the patient to another ventilator or to a different form of breathing support,” the FDA’s 2014 notice last indicated.
| Legal Help for Puritan Bennett 980 Ventilator Patients
If you or someone you know suffered injuries or death related to the PB980 recall, you may have valuable legal rights. Parker Waichman offers free, no-obligation case evaluations. For more information, fill out our online form or call one of our experienced personal injury attorneys today at 1-800-YOURLAWYER (1-800-968-7529).