Nellcor Puritan Bennett 840 Ventilator System (Model 840)

• • Terminated Z-1809-2014 FDA Class II ·initiated 4 Jun 2014

  In the case of a loss of GUI display due to a Backlight Inverter PCBA failure, the ventilator continues to provide uninterrupted ventilatory support at the programmed settings for the patient. However, there is a loss of display and thus there is a necessity to move the patient to another ventilator.

• • Terminated Z-1844-2014 FDA Class II ·initiated 3 Jun 2014

  Covidien is conducting a medical device field correction for specific Puritan Bennett 840 Ventilators due to customer reports of loss of graphical user interface (GUI) display information while the ventilator continues to provide breath support.

• • Terminated Z-0611-2014 FDA Class I ·initiated 16 Dec 2013

  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.

• 2 recalls, same reason

  • Terminated Z-0822-2014 FDA Class II ·initiated 25 Jan 2013
  • Terminated Z-0821-2014 FDA Class II ·initiated 25 Jan 2013

  Covidien is correcting labeling to clarify the operational life of the oxygen sensor (O2 sensor), PN 4-072214-00 used in the Puritan Bennett" 840, and PN, G-062010-00, used in Puritan Bennett" 740, and760 ventilator systems. The Operators Manual for PB840 states a nominal life of one year and the Addendum incorrectly states 2 years.

• • Terminated Z-1692-2008 FDA Unclassified (pre-2012) ·initiated 21 Mar 2008

  Wiring in battery back-up power supply may short and cause thermal damage to ventilator.

• • Terminated Z-0760-2007 FDA Unclassified (pre-2012) ·initiated 12 Mar 2007

  In rare instances, the safety valve may remain open after an occlusion is resolved. If the safety valve does not reset, the ventilator will detect a circuit disconnect condition. When this happens, the ventilator will annunciate a high-urgency audible alarm and the ventilator will not resume normal operation.

• • Terminated Z-1085-05 FDA Unclassified (pre-2012) ·initiated 20 Apr 2005

  Manufacturing defect at contract manufacturer, employee error, poor training, improper inspection.

510(k) Number

K970460 ↗

FDA Product Code

CBK

Device Class

Class II

Regulation

21 CFR Part 868.5895

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Proportional Solenoid Valve

  Class II

  FDA 510(k) K922102 Active Cleared 15 Sep 1994

• Puritan-Bennett Helios Portable Liquid Oxygen System

  Class II

  FDA 510(k) K993220 Active Cleared 22 Oct 1999

• Puritan-Bennett Aeris 590 Oxygen Concentrator with Oci

  Class II

  FDA 510(k) K993088 Active Cleared 8 Oct 1999

• Companion 318 Nasal Cpap Diagnostics System

  Class II

  FDA 510(k) K910194 Active Cleared 13 May 1991

• Puritan-Bennett Companion 320 I/E

  Class II

  FDA 510(k) K934804 Active Cleared 27 Feb 1995

• 7200 Microprocess Vent Sys/Model 7202 Display Opt

  Class II

  FDA 510(k) K862604 Active Cleared 1 Aug 1986

See all devices from Puritan Bennett Corp. →

• What is the intended use of the Nellcor Puritan Bennett 840 Ventilator System?

  The Nellcor Puritan Bennett 840 Ventilator System is designed to provide ventilatory support for patients across a range of ages, from infant to adult, in clinical ventilation settings.

• Is the Nellcor Puritan Bennett 840 Ventilator System reusable?

  Yes, the Nellcor Puritan Bennett 840 Ventilator System is supplied as a reusable system for use in facility environments.

• What is the regulatory classification of the Nellcor Puritan Bennett 840 Ventilator System?

  The Nellcor Puritan Bennett 840 Ventilator System is classified as a Class II medical device.

• Is the Nellcor Puritan Bennett 840 Ventilator System sterile?

  There is no indication of sterility provided in the data for the Nellcor Puritan Bennett 840 Ventilator System.