Covidien, Puritan Bennett 8. Series Ventilator.

Covidien, Puritan Bennett 8. Series Ventilator.

Recall Class: Class IDate Recall Initiated: December 1. Product(s): Puritan Bennett 8. Series Ventilator. Model/catalog/lot numbers: Software Part Number 4- 0.

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Revision AB- AGRange of manufacturing and distribution dates: Manufactured: April 3. March 1. 2, 2. 01.

Distributed: August 1, 2. October 3. 1, 2. 01. Use: A critical care ventilator that provides continuous ventilation for infant, pediatric, and adult patients. Recalling Firm: Covidien. Gunbarrel Avenue.

Boulder, Colorado 8. Reason for Recall: Due to a software problem, a diagnostic code (XB0. This causes the ventilator to stop functioning, triggering the safety alarm and causing the patient to suddenly be required to breathe on his or her own. These devices are used on critically ill patients who may not be able to continue breathing without the ventilator. This product may cause serious adverse health consequences, including death. Public Contact: Customers with questions regarding this recall can contact Covidien Technical Services at 8. Monday through Friday, from 6 AM to 5 PM Pacific Time (Menu option # 4).

Ventilation Solutions Built on a Solid Foundation. At Medtronic we believe mechanical ventilation can and should be more natural. A disposable expiratory filter and drain system designed for the Puritan Bennett

Customer service (Menu option # 3) is available Monday through Friday from 8 AM to 6: 3. PM Eastern Time. FDA District: Denver District. FDA Comments: On December 1. Covidien sent its customers an Urgent Medical Device Voluntary Field Correction letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.

Customers were instructed to continue using their Puritan Bennett 8. There are several ways to install the software update. To initiate the process for updating the software and select the method for an individual facility, customers should go to the software update management portal at www. PB8. 40technicalupdate. 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. Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to Med. Watch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

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• Puritan Bennett 840 Series Ventilator - Software Problem. Share; Tweet; Linkedin; Pin it; More sharing options. Linkedin; Pin it; Email; Print; Recall Class: Class I. Date Recall Initiated: December 16, 2013.