Recall Z-0611-2014 ยท CBK Ventilator, Continuous, Facility Use
Covidien
Puritan Bennett 840 ventilator systems software part number 4-070212-85, revision AB-AG. The intended use of the product is to provide mechanical ventilation to patients.
| Date | Jan 3, 2014 (initiated Dec 16, 2013) |
| Status | Terminated |
| Reason | Covidien is conducting a voluntary field corrective action on Puritan Bennett 840 ventilator systems with certain software revisions in response to customer reports of ventilator diagnostic code XB0069 in which the device stops mechanical ventilation due to a software error. |
| Root cause | Software design |
| Action | Covidien sent 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 840 ventilators until it is feasible to install the software update discussed in the letter. Covidien has developed a software solution to address this issue. Upon availability, there will be several ways to install the software update. To initiate the process for updating your software and to select the method that best suits your facil |
| Quantity | 16,923 US, 39,372 OUS |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Austria, Estonia, Belgium, Spain, Italy, Poland, Bulgaria, Finland, Portugal, Switzerland, France, Lithuania, Romania, Cyprus, Great Britain, Czech Republic, Greece, Latvia, Slovenia, Germany, Hungary, Slovak Republic, Ireland, Netherl |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001646 | PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION Puritan Bennett Corp., Oct 20, 2000 |
| K020357 | 800 SERIES EASYNEB NEBULIZER Nellcor Puritan Bennett, Inc., Aug 7, 2002 |
| K053388 | MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTION Puritan Bennett Corp., Apr 4, 2006 |
| K970460 | NELLCOR PURITAN BENNETT, 840 VENTILATOR SYSTEM (MODEL 840) Puritan Bennett Corp., Apr 30, 1998 |
| K984535 | PURITAN-BENNETT 840 VENTILATORY SYSTEM WITH BILEVEL OPTION Puritan Bennett Corp., Dec 28, 1998 |
| K993071 | PURITAN-BENNETT VENTILATOR SYSTEM WITH ET/TRACHEOSTOMY TUBE COMPENSATION, TC, OPTION, MODEL 840 Puritan Bennett Corp., Nov 24, 1999 |