Palmtop Ventilator, Models Ptv-8, Ptv-10

• • Terminated Z-2593-2014 FDA Class I ·initiated 8 Aug 2014

  CareFusion has identified a potential for damage to the power connector on the EnVe and ReVel ventilators due to misconnection by the operator. The input port on the ventilators must have the adapters correctly aligned to function properly. Incorrect alignment may cause the pins in the connector to bend, causing the PTV AC power adapter and/or PTV Auto Lighter Power Cord to be shortened, and pre

• • Terminated Z-2006-2012 FDA Class I ·initiated 19 Jun 2012

  CareFusion identified that the EnVe Ventilator may not hold the set Positive End Expiratory Pressure (PEEP) value either intermittently or continuously or it may alarm for a Patient Circuit Fault. The unit will activate either a Low PEEP or Patient Circuit Fault Alarm both audibly and Visually to alert the healthcare professional. Ventilation delivery to the patient may be compromised.

• • Terminated Z-0074-2012 FDA Unclassified (pre-2012) ·initiated 12 Sep 2011

  CareFusion has identified potential risks associated with the EnVe ventilator manufactured between December 2010 and May 2011. There are 3 issues that can result in ventilation delivery to the patient being interrupted. CareFusion will be contacting facilities to coordinate implementation of the necessary corrective actions.

• • Terminated Z-0857-2010 FDA Unclassified (pre-2012) ·initiated 8 Jan 2010

  CareFusion is recalling the EnVe Ventilator because the EnVe Ventilator does not fully meet applicable standards for immunity to electro-Magnetic Interference (EMI) when tested in the laboratory environment. CareFusion has identified certain device malfunctions that may affect device performance and patient safety in the intended use environment.

510(k) Number

K070594 ↗

FDA Product Code

CBK

Device Class

Class II

Regulation

21 CFR Part 868.5895

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Ltv 1000 Ventilator

  Class II

  FDA 510(k) K051767 Active Cleared 29 Jul 2005

• Pulmonetic Systems Ltv 1200 MR Conditional Ventilator

  Class II

  FDA 510(k) K083688 Active Cleared 18 Mar 2009

• Modification to Lap Top Ventilator (Ltv)

  Class II

  FDA 510(k) K010608 Active Cleared 20 Mar 2001

• Automobile Lighter Power Cord

  Class II

  FDA 510(k) K060549 Active Cleared 4 May 2006

• Ltv 1200 Ventilator

  Class II

  FDA 510(k) K060647 Active Cleared 25 May 2006

• Ltv 1000

  Class II

  FDA 510(k) K984056 Active Cleared 12 Apr 1999

See all devices from Pulmonetic Systems, Inc. →