Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Medical Devices

  • Print
  • Share
  • E-mail
-

Puritan-Bennett Ventilator, Model 840 containing Revision E-level software

Class I Recall
Date Recall Initiated:
 December 22, 2000
Product:
 Puritan-Bennett Ventilator, Model 840 containing Revision E-level software.
Use:
 To mechanically control or assist a patient's breathing by delivering a predetermined percent of oxygen in breathing gases. This device is used in hospital facilities.
Recalling Firm:
 Puritan-Bennett Corporation
2200 Faraday Ave.
Carlsbad, California 92008
Reason for Recall:
 Short bursts of breathing gases delivered at a high pressure may occur while using this device. These increases of pressure occurred with the Revision E version software.
Public Contact:
 Puritan-Bennett Corporation
4280 Hacienda Dr.
Pleasanton, CA 94588
Phone: 925-463-4371
FDA District:
 Los Angeles, California
FDA Comment:
 FDA considers there to be a risk of over-pressure to the lungs (barotrauma) for patients whose weight is 20 kg (44 pounds) or less.
-
-