Covidien, Puritan Bennett 980 Ventilator Recalled, May Not Deliver Enough OxygenSep 3, 2015
A Class I recall has been issued for the Puritan Bennett 980 Ventilator, manufactured by Covidien, because the system may deliver less air than what is programmed. According to a safety alert posted on the U.S. Food and Drug Administration's (FDA's) website, the recall affects the following products codes: 980U1ENDIUU, 980U1ENDIUUS, 980U3ENDIUU, 980U3ENDIUUS, 980N1ENDIUU, 980N1ENDIUUS, 980N3ENDIUU, 980N3ENDIUUS. The recalled lots were manufactured from March 2014 to June 2015 and distributed from March 1, 2014 to June 17, 2015.
Class I recalls are for products whose defects can reasonably lead to serious injuries or death; it is the FDA's most serious recall status. The PB980 provides constant breathing support to adult, children and premature babies weighing at least 10.6 ounces. According to the recall notice, "When the ventilator is in neonatal Volume Control Plus (VC+) mode with active humidification, 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."
"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."
Covidien sent an Urgent: Field Corrective Action Notice to customers on July 17. The company plans to correct the error through a software update. Users are instructed, among other things, to ensure that patients using the VC+ in NeoMode receive adequate ventilation.