Puritan Bennett Ventilator Recall Issued Over Respiratory Problems

A Class I medical device recall has been issued for certain ventilation systems, after several reports were received of the machines failing to administer the correct amount of oxygen to patients, potentially resulting in life-threatening injuries and even death if not recognized. 

The Puritan Bennett 980 Ventilator system recall was announced by the FDA on August 14, following complaints from hospital workers indicating the preset tidal volumes were not delivering the designated amount of oxygen to patients. To date, no injuries or deaths have been reported.

The recalled 980 Ventilation System is designed to be used on neonatal and adult populations who are admitted to hospitals or medical centers requiring respiratory support or need mechanical ventilation.

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The ventilation systems may create hazardous situations for patients including compromised respiratory function if the correct tidal volumes are not delivered.

Tidal volumes are a medical term used to define the lung volume representing the normal volume of air displaced between normal inhalation and exhalation when extra effort is not applied. Doctors and physicians predetermine the patients tidal volumes based on the individuals medical history, age and general health.

The recall includes Puritan Bennett 980 Ventilator Systems, with Universal and Neonatal Models. The recalled units have model codes 980U1ENDIUU, 980U1ENDIUUS, 980U3ENDIUU, 980U3ENDIUUS, 980N1ENDIUU, 980N1ENDIUUS, 980N3ENDIUU and 980N3ENDIUUS.

The ventilation units were manufactured by Covidien LP, of Boulder, Colorado where they were distributed for sale worldwide at the hospital user level in the U.S., Canada, United Arab Emirates, Argentina, Australia, Bahrain, Brazil, Chile, Colombia, Costa Rica, Egypt, Ireland, Israel, Jordan, Japan, Kuwait, Lebanon, Morocco, Mexico, Panama, Peru, Qatar, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Turkey and Uruguay.

Covidien LP sent defect notices and letters to consignees on July 17, 2015 with instructions stating that no machine will be returned and a reconfiguration of the affected ventilators will be scheduled to be repaired on-site. Customers with further questions may contact Michael Ronningen from Covidien LP at 303-876-8870.

Class I recalls are the highest degree of recall set forth by the FDA and indicate that there is a reasonable probability that use of or exposure to a certain product will cause serious adverse health consequences or death.


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